{"id":10678,"date":"2026-03-25T12:00:53","date_gmt":"2026-03-25T04:00:53","guid":{"rendered":"https:\/\/www.behealthventures.com\/?post_type=knowledge_base&#038;p=10678"},"modified":"2026-04-21T11:22:42","modified_gmt":"2026-04-21T03:22:42","slug":"fda-%e5%af%a9%e6%9f%a5%e8%a6%96%e8%a7%92%ef%bd%9cai-%e9%86%ab%e7%99%82%e7%94%a2%e5%93%81-intended-use-%e6%80%8e%e9%ba%bc%e5%af%ab%ef%bc%9f7-%e5%a4%a7%e5%b8%b8%e8%a6%8b%e9%80%80%e4%bb%b6%e5%9c%b0","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/zh-hant\/knowledge_base\/fda-%e5%af%a9%e6%9f%a5%e8%a6%96%e8%a7%92%ef%bd%9cai-%e9%86%ab%e7%99%82%e7%94%a2%e5%93%81-intended-use-%e6%80%8e%e9%ba%bc%e5%af%ab%ef%bc%9f7-%e5%a4%a7%e5%b8%b8%e8%a6%8b%e9%80%80%e4%bb%b6%e5%9c%b0\/","title":{"rendered":"FDA \u5be9\u67e5\u8996\u89d2\uff5cAI \u91ab\u7642\u7522\u54c1 Intended Use \u600e\u9ebc\u5beb\uff1f7 \u5927\u5e38\u898b\u9000\u4ef6\u5730\u96f7\u8207\u4fee\u6b63\u7bc4\u672c"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-10682 size-full\" src=\"https:\/\/behealthventures.com\/wp-content\/uploads\/2026\/03\/iStock-2245658628.jpg\" alt=\"\" width=\"724\" height=\"483\" \/><\/p>\n<p>\u6bd4\u7ffc\u751f\u91ab\u5275\u6295\u91ab\u7642\u4e8b\u52d9\u526f\u7e3d \u6c88\u4fe1\u7def<\/p>\n<p><span data-contrast=\"auto\">\u4f60\u4ee5\u70ba<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u91ab\u7642\u7522\u54c1\u6703\u8f38\u5728\u6a21\u578b\u6548\u80fd\uff0c\u7d50\u679c\u771f\u6b63\u8b93\u6848\u5b50\u5361\u4f4f\u7684\uff0c\u5e38\u5e38\u662f\u00a0<\/span><span data-contrast=\"auto\">Intended Use<\/span><span data-contrast=\"auto\">\uff08\u9810\u671f\u7528\u9014\uff09\u90a3\u4e00\u5169\u53e5\u300c\u770b\u8d77\u4f86\u5f88\u5408\u7406\u300d\u7684\u63cf\u8ff0\u3002<\/span><\/p>\n<p>\u5728<span data-contrast=\"auto\">\u00a0FDA\u00a0<\/span><span data-contrast=\"auto\">\u7684\u8a9e\u8a00\u88e1\uff0c<\/span><span data-contrast=\"auto\">Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u4e0d\u662f\u884c\u92b7\u6587\u6848\uff0c\u4e5f\u4e0d\u662f\u9858\u666f\u5ba3\u793a\uff1b\u5b83\u662f\u5206\u985e\u908f\u8f2f\u7684\u8d77\u9ede\u3002\u5c24\u5176\u5728\u5f71\u50cf<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u9818\u57df\uff0c<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\/\u00a0<\/span><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\u00a0\/\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">Triage\/Notification<\/span><span data-contrast=\"auto\">\uff09\u4e4b\u6240\u4ee5\u88ab\u5340\u5206\uff0c\u4e3b\u8981\u770b<\/span><span data-contrast=\"auto\">\u00a0Intended Use<\/span><span data-contrast=\"auto\">\u3001\u8f38\u51fa\u578b\u614b\uff0c\u4ee5\u53ca\u5c0d\u61c9\u7684\u6cd5\u898f\u5206\u985e\u8207<\/span><span data-contrast=\"auto\">\u00a0product code<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4f60\u5beb\u932f\u4e00\u500b\u52d5\u8a5e\uff0c\u5e38\u898b\u5f8c\u679c\u4e0d\u662f\u300c\u5c0f\u4fee\u5c31\u597d\u300d\uff0c\u800c\u662f\uff1a\u6574\u500b\u7522\u54c1\u88ab\u4f60\u81ea\u5df1\u63cf\u8ff0\u6210\u53e6\u4e00\u500b\u985e\u5225\uff0c\u5f8c\u7e8c\u7684<\/span><span data-contrast=\"auto\">\u00a0test strategy<\/span><span data-contrast=\"auto\">\u3001\u81e8\u5e8a\u8b49\u64da\u3001\u6a19\u793a\uff08<\/span><span data-contrast=\"auto\">labeling<\/span><span data-contrast=\"auto\">\uff09\u548c<\/span><span data-contrast=\"auto\">\u00a0predicate\u00a0<\/span><span data-contrast=\"auto\">\u8ad6\u8b49\u6703\u5168\u90e8\u8ddf\u8457\u6b6a\u6389\u3002\u4e0b\u9762\u6211\u5011\u7528<\/span><span data-contrast=\"auto\">\u00a0Reviewer\u00a0<\/span><span data-contrast=\"auto\">\u7684\u95b1\u8b80\u7bc0\u594f\uff0c\u5e36\u4f60\u628a\u6700\u5bb9\u6613\u8e29\u7684\u96f7\u62c6\u958b\u4f86\u770b\uff0c\u4e26\u7d66\u4f60\u4e00\u5957\u53ef\u4ee5\u843d\u5730\u7684\u4fee\u6b63\u5beb\u6cd5\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u4e00\u3001\u5148\u628a\u4e09\u4ef6\u4e8b\u8b1b\u6e05\u695a\uff1aCADe\u3001CADx\u3001CADt\u00a0\u7684\u7d05\u7dda\u5dee\u5728\u54ea\uff1f\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u5f71\u50cf<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u5728\u5be9\u67e5\u4e0a\uff0c\u6700\u5e38\u898b\u7684\u300c\u7b2c\u4e00\u6027\u539f\u7406\u300d\u5176\u5be6\u5f88\u7c21\u55ae\uff1a\u4f60\u8f38\u51fa\u7684\u662f\u4ec0\u9ebc\uff0c\u5c31\u5728\u6697\u793a\u4f60\u5728\u5e6b\u91ab\u5e2b\u505a\u54ea\u4e00\u6bb5\u6c7a\u7b56\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">detection<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u7684\u6838\u5fc3\u662f\u300c\u5075\u6e2c\/\u5b9a\u4f4d\u53ef\u7591\u5340\u57df\u300d\uff0c\u5178\u578b\u8f38\u51fa\u662f<\/span><span data-contrast=\"auto\">\u00a0ROI\/<\/span><span data-contrast=\"auto\">\u6a19\u8a18\uff08\u5708\u51fa\u3001\u6846\u51fa\u3001\u71b1\u5340\u63d0\u793a\uff09\uff0c\u4f46\u4e0d\u505a\u826f\u60e1\u6027\u7279\u5fb5\u5316\uff0c\u4e0d\u7d66\u8a3a\u65b7\u7d50\u8ad6\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">diagnosis\/characterization<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\u00a0\u7684\u6838\u5fc3\u662f\u300c\u7279\u5fb5\u5316\/\u8a3a\u65b7\u6027\u8f38\u51fa\u300d\uff0c\u4f8b\u5982\u60e1\u6027\u6a5f\u7387\u3001\u5206\u7d1a\u3001\u56b4\u91cd\u5ea6\u3001\u5206\u671f\u7b49\uff0c\u901a\u5e38\u662f\u5efa\u7acb\u5728<\/span><span data-contrast=\"auto\">\u00a0ROI\u00a0<\/span><span data-contrast=\"auto\">\u6216\u7279\u5fb5\u4e4b\u4e0a\uff0c\u8f38\u51fa\u578b\u614b\u6703\u66f4\u8cbc\u8fd1\u81e8\u5e8a\u6c7a\u7b56\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">triage\/notification<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\u00a0\u7684\u6838\u5fc3\u662f\u300c\u5206\u6d41\/\u512a\u5148\u6392\u5e8f\u300d\uff0c\u5178\u578b\u8f38\u51fa\u662f<\/span><span data-contrast=\"auto\">\u00a0case-level\u00a0<\/span><span data-contrast=\"auto\">\u7684<\/span><span data-contrast=\"auto\">\u00a0flag \/ priority score<\/span><span data-contrast=\"auto\">\uff0c\u7528\u65bc\u91cd\u6392<\/span><span data-contrast=\"auto\">\u00a0worklist\u00a0<\/span><span data-contrast=\"auto\">\u6216\u901a\u77e5\u4f7f\u7528\u8005\uff0c\u4e14\u901a\u5e38\u4e0d\u505a\u75c5\u7076\u5b9a\u4f4d\uff08\u4e0d<\/span><span data-contrast=\"auto\">\u00a0localize<\/span><span data-contrast=\"auto\">\uff09\u3001\u4e5f\u4e0d\u63d0\u4f9b\u8a3a\u65b7\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u518d\u628a\u5b83\u5c0d\u7167\u5230\u6cd5\u898f\u8207<\/span><span data-contrast=\"auto\">\u00a0product code<\/span><span data-contrast=\"auto\">\uff0c\u4f60\u6703\u767c\u73fe<\/span><span data-contrast=\"auto\">\u00a0FDA\u00a0<\/span><span data-contrast=\"auto\">\u7684\u5206\u985e\u8a9e\u8a00\u5176\u5be6\u5f88\u4e00\u81f4\uff1a<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff1a<\/span><span data-contrast=\"auto\">21 CFR 892.2080<\/span><span data-contrast=\"auto\">\uff0c\u5e38\u898b<\/span><span data-contrast=\"auto\">\u00a0product code\u00a0QAS<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\uff08\u764c\u75c7\u53ef\u7591\u75c5\u7076\uff09\uff1a<\/span><span data-contrast=\"auto\">21 CFR 892.2060<\/span><span data-contrast=\"auto\">\uff0c\u5e38\u898b<\/span><span data-contrast=\"auto\">\u00a0product code\u00a0POK<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADx\u00a0combined<\/span><span data-contrast=\"auto\">\uff1a<\/span><span data-contrast=\"auto\">21 CFR 892.2090<\/span><span data-contrast=\"auto\">\uff08\u5075\u6e2c\uff0b\u8a3a\u65b7\uff09\uff0c\u4f8b\u5982\u4e73\u623f\u76f8\u95dc\u7684\u00a0<\/span><span data-contrast=\"auto\">QDQ<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u53e6\u6709\u591a\u7a2e\u00a0<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u5075\u6e2c\u5c0e\u5411\u7684<\/span><span data-contrast=\"auto\">\u00a0product code<\/span><span data-contrast=\"auto\">\uff08\u5982<\/span><span data-contrast=\"auto\">\u00a0NWE\/OEB\/OMJ\/MYN\u00a0<\/span><span data-contrast=\"auto\">\u7b49\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u9019\u4e9b\u4e0d\u662f\u80cc\u540d\u8a5e\uff0c\u4f60\u5728<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u88e1\u9078\u7684\u52d5\u8a5e\u8207\u8f38\u51fa\u63cf\u8ff0\uff0c\u662f\u5728\u5e6b<\/span><span data-contrast=\"auto\">\u00a0Reviewer\u00a0<\/span><span data-contrast=\"auto\">\u5224\u65b7\u4f60\u843d\u5728\u54ea\u500b\u6876\u5b50\u88e1\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u4e8c\u3001Reviewer\u00a0\u5728\u4f60\u300c510(k)\u00a0\u7b2c\u4e00\u7ae0\u300d\u8166\u4e2d\u6703\u5192\u51fa\u7684\u00a05\u00a0\u500b\u8cea\u7591:\u00a0<\/strong><\/p>\n<p><strong>1)\u00a0\u4f60\u5230\u5e95\u662f\u00a0CADe\u3001CADx\uff0c\u9084\u662f\u00a0CADt\uff1f\uff08\u7522\u54c1\u78bc\u6c7a\u5b9a\u4f60\u8981\u4ea4\u4ec0\u9ebc\u8b49\u64da\uff09\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u9019\u662f\u6700\u5e38\u898b\u7684\u81f4\u547d\u9ede\u3002<\/span><span data-contrast=\"auto\">\u00a0FDA\u00a0<\/span><span data-contrast=\"auto\">\u5c0d\u4e09\u8005\u7684\u5340\u5206\uff0c\u4e3b\u8981\u9760<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u8207\u8f38\u51fa\u578b\u614b\uff0c\u800c\u4e0d\u662f\u4f60\u7528\u4ec0\u9ebc\u6a21\u578b\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5178\u578b\u932f\u6cd5\u662f\uff1a\u5634\u5df4\u8aaa\u8981\u8d70\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff08\u5206\u6d41\uff09\uff0c\u4f46\u6587\u5b57\u537b\u5beb\u51fa\u300c\u6846\u51fa\u51fa\u8840\u9ede\/\u6a19\u8a18\u75c5\u7076\u4f4d\u7f6e\u300d\u3002\u4f60\u4e00\u65e6\u63cf\u8ff0\u51fa<\/span><span data-contrast=\"auto\">\u00a0localization<\/span><span data-contrast=\"auto\">\uff0c<\/span><span data-contrast=\"auto\">Reviewer\u00a0<\/span><span data-contrast=\"auto\">\u5f88\u81ea\u7136\u6703\u628a\u4f60\u5f80\u00a0<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADe+<\/span><span data-contrast=\"auto\">\uff08\u751a\u81f3<\/span><span data-contrast=\"auto\">\u00a0combined<\/span><span data-contrast=\"auto\">\uff09\u65b9\u5411\u63a8\uff0c\u56e0\u70ba\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\u00a0\u7684\u5178\u578b\u908f\u8f2f\u5c31\u662f<\/span><span data-contrast=\"auto\">\u00a0case-level flag<\/span><span data-contrast=\"auto\">\u3001\u901a\u5e38\u4e0d\u5b9a\u4f4d\u4e5f\u4e0d\u8a3a\u65b7\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4fee\u6b63\u539f\u5247\uff1a<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u4f60\u8981\u8d70\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff0c\u5c31\u628a\u8f38\u51fa\u6536\u6582\u70ba\u300c<\/span><span data-contrast=\"auto\">flag\/priority\/notify<\/span><span data-contrast=\"auto\">\u300d\uff0c\u907f\u514d\u4efb\u4f55\u6697\u793a\u4f60\u5728\u505a<\/span><span data-contrast=\"auto\">\u00a0lesion-level marking<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u4f60\u8981\u505a<\/span><span data-contrast=\"auto\">\u00a0marking<\/span><span data-contrast=\"auto\">\uff0c\u5c31\u8aa0\u5be6\u627f\u8a8d\u4f60\u662f\u00a0<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\uff0c\u4e26\u628a\u300c\u4e0d\u8a3a\u65b7\u3001\u4e0d\u5206\u6d41\u300d\u5beb\u6e05\u695a\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>2)\u00a0\u4f60\u60f3\u7528\u300cCDS\u300d\u7576\u4fdd\u8b77\u5098\uff1f\u5f71\u50cf\u00a0AI\u00a0\u5e7e\u4e4e\u4e00\u5b9a\u662f\u00a0Device\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u5f88\u591a\u5718\u968a\u6703\u8aaa\u300c\u6211\u5011\u5011\u53ea\u662f<\/span><span data-contrast=\"auto\">\u00a0CDS<\/span><span data-contrast=\"auto\">\uff0c\u4e0d\u662f\u91ab\u6750\u300d\u3002\u4f46\u4f60\u63d0\u4f9b\u7684\u53c3\u8003\u6a94\u5df2\u7d93\u628a\u95dc\u9375\u5beb\u5f97\u5f88\u76f4\u767d\uff1a<\/span><span data-contrast=\"auto\">FDA\u00a0<\/span><span data-contrast=\"auto\">\u7684<\/span><span data-contrast=\"auto\">\u00a02022\u00a0<\/span><span data-contrast=\"auto\">\u6700\u7d42\u7248<\/span><span data-contrast=\"auto\">\u00a0CDS guidance\u00a0<\/span><span data-contrast=\"auto\">\u4ee5\u56db\u689d<\/span><span data-contrast=\"auto\">\u00a0criteria\u00a0<\/span><span data-contrast=\"auto\">\u5224\u65b7<\/span><span data-contrast=\"auto\">\u00a0non-device CDS<\/span><span data-contrast=\"auto\">\uff0c\u800c\u53ea\u8981\u4efb\u4e00\u689d\u4e0d\u7b26\u5408\uff0c\u5c31\u6703\u88ab\u8996\u70ba<\/span><span data-contrast=\"auto\">\u00a0device<\/span><span data-contrast=\"auto\">\uff08\u901a\u5e38\u8d70<\/span><span data-contrast=\"auto\">\u00a0Class II \/ 510(k)<\/span><span data-contrast=\"auto\">\uff09\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5c0d\u5f71\u50cf<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u4f86\u8aaa\uff0c\u6700\u81f4\u547d\u7684\u662f<\/span><span data-contrast=\"auto\">\u00a0criterion 1<\/span><span data-contrast=\"auto\">\uff1a\u53ea\u8981\u4f60<\/span><span data-contrast=\"auto\">\u00a0acquire\/process\/analyze medical image\u00a0<\/span><span data-contrast=\"auto\">\u6216<\/span><span data-contrast=\"auto\">\u00a0signal<\/span><span data-contrast=\"auto\">\uff0c\u5c31\u5e7e\u4e4e\u4e00\u5b9a\u5931\u6557\uff0c\u56e0\u6b64\u591a\u6578\u5f71\u50cf<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u6703\u843d\u5728<\/span><span data-contrast=\"auto\">\u00a0device\u00a0<\/span><span data-contrast=\"auto\">\u76e3\u7ba1\u7bc4\u570d\u5167\uff08\u4f8b\u5982<\/span><span data-contrast=\"auto\">\u00a0QAS\/POK\/QDQ<\/span><span data-contrast=\"auto\">\uff09\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5be6\u6230\u63d0\u9192\uff1a\u4f60\u53ef\u4ee5\u628a\u7522\u54c1\u5b9a\u4f4d\u6210\u300c\u8f14\u52a9\u91ab\u5e2b\u5224\u8b80\u300d\uff0c\u4f46\u4e0d\u8981\u5728<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u6697\u793a\u300c\u53d6\u4ee3\/\u66ff\u91ab\u5e2b\u4e0b\u7d50\u8ad6\u300d\u3002\u56e0\u70ba<\/span><span data-contrast=\"auto\">\u00a0FDA\u00a0<\/span><span data-contrast=\"auto\">\u5728\u610f\u7684\uff0c\u662f\u4f60\u7a76\u7adf\u5728<\/span><span data-contrast=\"auto\">\u00a0support HCP judgment<\/span><span data-contrast=\"auto\">\uff0c\u9084\u662f\u5728<\/span><span data-contrast=\"auto\">\u00a0substitute it<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>3) User profile\u00a0\u5beb\u592a\u5bec\uff1a\u4f60\u4e00\u5beb\u300cGP\/\u8b77\u7406\u5e2b\u53ef\u7528\u300d\uff0c\u98a8\u96aa\u60f3\u50cf\u7acb\u523b\u5347\u7d1a\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u7576\u4f60\u63d0\u5230\u300c\u8fd1\u671f\u6848\u4f8b\u90fd\u9650\u5b9a<\/span><span data-contrast=\"auto\">\u00a0trained professionals<\/span><span data-contrast=\"auto\">\u300d\uff0c\u9019\u500b\u65b9\u5411\u5728\u5be9\u67e5\u8a9e\u5883\u4e0a\u662f\u5c0d\u7684\uff1a<\/span><span data-contrast=\"auto\">FDA\u00a0<\/span><span data-contrast=\"auto\">\u5728\u5224\u65b7\u662f\u5426\u652f\u63f4<\/span><span data-contrast=\"auto\">\u00a0HCP judgment\u00a0<\/span><span data-contrast=\"auto\">\u6642\uff0c\u672c\u4f86\u5c31\u6703\u628a<\/span><span data-contrast=\"auto\">\u00a0user<\/span><span data-contrast=\"auto\">\uff08\u662f\u5426\u70ba<\/span><span data-contrast=\"auto\">\u00a0HCP<\/span><span data-contrast=\"auto\">\u3001\u662f\u5426\u5177\u5099\u5224\u8b80\u80fd\u529b\uff09\u8996\u70ba\u6838\u5fc3\u56e0\u7d20\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u66f4\u52d9\u5be6\u7684\u5beb\u6cd5\u662f\uff1a\u628a<\/span><span data-contrast=\"auto\">\u00a0user\u00a0<\/span><span data-contrast=\"auto\">\u5beb\u6210\u300c\u5177\u5099\u76f8\u95dc\u5224\u8b80\u8a13\u7df4\u4e4b\u91ab\u7642\u5c08\u696d\u4eba\u54e1\u300d\uff0c\u907f\u514d\u628a\u7522\u54c1\u63cf\u8ff0\u6210\u300c\u964d\u4f4e\u9580\u6abb\u8b93\u975e\u5c08\u5bb6\u4e5f\u80fd\u505a\u5c08\u5bb6\u5224\u65b7\u300d\u3002\u5f8c\u8005\u5f88\u5bb9\u6613\u8b93<\/span><span data-contrast=\"auto\">\u00a0Reviewer\u00a0<\/span><span data-contrast=\"auto\">\u806f\u60f3\u5230\u8aa4\u7528\u98a8\u96aa\u8207<\/span><span data-contrast=\"auto\">\u00a0automation bias<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>4)\u00a0\u5ba3\u7a31\u7bc4\u570d\u00a0vs\u00a0\u6578\u64da\u4ee3\u8868\u6027\uff1a\u4f60\u5beb\u300c\u6240\u6709\u6210\u4eba\u00a0CT\u300d\uff0c\u5c31\u5f97\u6e96\u5099\u88ab\u8ffd\u554f\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u4f60\u9644\u6a94\u5728\u8da8\u52e2\u6bb5\u843d\u9ede\u51fa\uff1a\u8fd1\u5e74<\/span><span data-contrast=\"auto\">cleared indications<\/span><span data-contrast=\"auto\">\u5e38\u805a\u7126\u5728<\/span><span data-contrast=\"auto\">detection\/<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">triage\/<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">segmentation\/<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">workflow support<\/span><span data-contrast=\"auto\">\uff0c\u800c\u4e0d\u662f\u300c\u55ae\u7368\u8a3a\u65b7\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u9019\u80cc\u5f8c\u7684\u8a9e\u611f\u662f\uff1a\u5ba3\u7a31\u8d8a\u5927\uff0c\u4ee3\u8868\u6027\u8207\u9a57\u8b49\u8ca0\u64d4\u8d8a\u5927\u3002\u6240\u4ee5\u5728<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u4e0a\uff0c\u6211\u5011\u5efa\u8b70\u7528\u300c\u81e8\u5e8a\u60c5\u5883\uff0b\u8f38\u5165\u578b\u614b\uff0b\u8f38\u51fa\u9650\u5236\u300d\u628a\u7bc4\u570d\u6536\u5f97\u6f02\u4eae\uff0c\u800c\u4e0d\u662f\u7528\u4e00\u53e5\u300c\u9069\u7528\u65bc\u6240\u6709\u2026\u300d\u628a\u81ea\u5df1\u903c\u9032\u6700\u96e3\u5b88\u7684\u6230\u5834\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>5)\u00a0\u4f60\u5728\u6587\u5b57\u88e1\u4e0d\u5c0f\u5fc3\u5beb\u51fa\u300c\u8a3a\u65b7\u6027\u8f38\u51fa\u300d\uff1a\u90a3\u4f60\u5c31\u4e0d\u662f\u00a0CADt\u00a0\u4e86<\/strong><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5f88\u591a\u5718\u968a\u4ee5\u70ba\u300c\u6211\u5011\u5011\u53ea\u662f\u63d0\u9192\u300d\uff1b\u4f46\u4f60\u4e00\u65e6\u5beb\u51fa\u00a0<\/span><span data-contrast=\"auto\">probability \/ malignancy likelihood \/ category \/ staging<\/span><span data-contrast=\"auto\">\u00a0\u9019\u985e\u8a3a\u65b7\u6027\u8f38\u51fa\uff0c\u8a9e\u610f\u4e0a\u5c31\u66f4\u63a5\u8fd1\u00a0<\/span><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">diagnostic\u00a0or risk stratification outputs<\/span><span data-contrast=\"auto\">\uff09\u3002<br \/>\n\u9019\u6703\u76f4\u63a5\u6539\u8b8a<\/span><span data-contrast=\"auto\">\u00a0reviewer\u00a0<\/span><span data-contrast=\"auto\">\u5c0d\u98a8\u96aa\u8207\u8b49\u64da\u7684\u76f4\u89ba\u9810\u671f\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u4e09\u3001\u4e00\u5957\u53ef\u4ee5\u76f4\u63a5\u62ff\u4f86\u7528\u7684\u00a0Intended Use\u00a0\u5beb\u4f5c\u6846\u67b6\uff08\u542b\u00a0Reviewer\u00a0\u6aa2\u6838\u9ede\uff09\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u4e0b\u9762\u9019\u5957\u4e0d\u662f\u300c\u6559\u4f60\u5beb\u6f02\u4eae\u300d\uff0c\u800c\u662f\u300c\u6559\u4f60\u5beb\u5f97\u53ef\u88ab\u5206\u985e\u3001\u53ef\u88ab\u9a57\u8b49\u3001\u53ef\u88ab\u5c0d\u7167\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u7b2c\u4e00\u6b65\uff1a\u5148\u9078\u4f60\u7684\u6838\u5fc3\u53e5\u578b\uff08\u628a\u52d5\u8a5e\u9078\u5c0d\uff09\u00a0<\/strong><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">QAS<\/span><span data-contrast=\"auto\">\uff09\u8a9e\u611f\uff1a<\/span><i><span data-contrast=\"auto\">identify\u00a0suspected findings \u2192 notify \/ prioritize for earlier\u00a0review<\/span><\/i><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">case-level\u00a0flag \/ priority<\/span><span data-contrast=\"auto\">\uff1b\u901a\u5e38\u4e0d\u5b9a\u4f4d\u3001\u4e0d\u8a3a\u65b7\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u8a9e\u611f\uff1a<\/span><i><span data-contrast=\"auto\">detect \/ highlight \/ mark suspicious\u00a0regions<\/span><\/i><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">ROI\/marking<\/span><span data-contrast=\"auto\">\uff0c\u4f46\u4e0d\u8a3a\u65b7\u3001\u4e0d\u5206\u6d41\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\uff08<\/span><span data-contrast=\"auto\">POK<\/span><span data-contrast=\"auto\">\uff09\u8a9e\u611f\uff1a<\/span><i><span data-contrast=\"auto\">characterize lesions \/ assess likelihood \/ categorization<\/span><\/i><span data-contrast=\"auto\">\uff08\u8a3a\u65b7\/\u7279\u5fb5\u5316\u8f38\u51fa\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4f60\u53ea\u8981\u628a\u9019\u500b\u52d5\u8a5e\u5c64\u7d1a\u9078\u5c0d\uff0c\u5f8c\u9762<\/span><span data-contrast=\"auto\">\u00a080%\u00a0<\/span><span data-contrast=\"auto\">\u7684\u4e00\u81f4\u6027\u554f\u984c\u6703\u81ea\u52d5\u6d88\u5931\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u7b2c\u4e8c\u6b65\uff1a\u628a\u8f38\u5165\/\u8f38\u51fa\u8b1b\u6210\u300c\u53ef\u6e2c\u8a66\u300d\u800c\u4e0d\u662f\u300c\u53ef\u60f3\u50cf\u300d\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u5beb\u6e05\u695a\uff1a<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u8f38\u5165\u662f\u4ec0\u9ebc\u5f71\u50cf\/\u8a0a\u865f\uff08<\/span><span data-contrast=\"auto\">DICOM CT\/MR\/CXR\u2026<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u8f38\u51fa\u662f<\/span><span data-contrast=\"auto\">\u00a0case-level flag \/ priority score<\/span><span data-contrast=\"auto\">\uff0c\u9084\u662f<\/span><span data-contrast=\"auto\">\u00a0lesion-level ROI\/marking<\/span><span data-contrast=\"auto\">\uff0c\u6216\u662f<\/span><span data-contrast=\"auto\">\u00a0probability\/category<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u56e0\u70ba<\/span><span data-contrast=\"auto\">\u00a0FDA\u00a0<\/span><span data-contrast=\"auto\">\u5340\u5206\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\u00a0\u7684\u95dc\u9375\u4e4b\u4e00\u5c31\u662f\u300c<\/span><span data-contrast=\"auto\">type of output<\/span><span data-contrast=\"auto\">\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u7b2c\u4e09\u6b65\uff1a\u628a\u300c\u81e8\u5e8a\u6d41\u7a0b\u5d4c\u5165\u9ede\u300d\u5beb\u51fa\u4f86\uff08\u4f60\u5728\u5e6b\u5fd9\u54ea\u4e00\u6bb5\uff09\u00a0<\/strong><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\u00a0\u5e38\u898b\u662f\u5728<\/span><span data-contrast=\"auto\">\u00a0worklist\/notification\u00a0<\/span><span data-contrast=\"auto\">\u6d41\u7a0b\u4e2d\uff0c\u7528\u65bc<\/span><span data-contrast=\"auto\">\u00a0re-order<\/span><span data-contrast=\"auto\">\u3001<\/span><span data-contrast=\"auto\">alerts<\/span><span data-contrast=\"auto\">\u3001<\/span><span data-contrast=\"auto\">notifications<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u5e38\u88ab\u63cf\u8ff0\u70ba<\/span><span data-contrast=\"auto\">\u00a0second reader<\/span><span data-contrast=\"auto\">\uff0c\u5438\u5f15\u6ce8\u610f\u529b\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\u00a0\u66f4\u9760\u8fd1<\/span><span data-contrast=\"auto\">\u00a0decision support after lesion identification<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4f60\u628a<\/span><span data-contrast=\"auto\">\u00a0workflow\u00a0<\/span><span data-contrast=\"auto\">\u5beb\u6e05\u695a\uff0c<\/span><span data-contrast=\"auto\">Reviewer\u00a0<\/span><span data-contrast=\"auto\">\u6703\u66f4\u5bb9\u6613\u628a\u4f60\u653e\u9032\u6b63\u78ba\u7684\u98a8\u96aa\u6846\u67b6\uff0c\u800c\u4e0d\u662f\u7528\u6700\u4fdd\u5b88\u65b9\u5f0f\u60f3\u50cf\u4f60\u5728\u300c\u66ff\u4ee3\u5224\u8b80\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u56db\u3001Deliverables\uff1a\u5728\u00a0DHF\u00a0\u88e1\u4f60\u81f3\u5c11\u8981\u6e96\u5099\u54ea\u4e9b\u7522\u51fa\u7269\uff1f\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u4f60\u539f\u672c\u5217\u7684<\/span><span data-contrast=\"auto\">\u00a0deliverables\u00a0<\/span><span data-contrast=\"auto\">\u5f88\u5c0d\uff0c\u6211\u5011\u53ea\u628a\u540d\u7a31\u505a\u6210\u66f4\u300c<\/span><span data-contrast=\"auto\">DHF\u00a0<\/span><span data-contrast=\"auto\">\u53e3\u5f91\u300d\u7684\u7248\u672c\uff0c\u8b93\u65b0\u5275\u5718\u968a\u66f4\u5bb9\u6613\u76f4\u63a5\u5c0e\u5165\uff1a<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">DOC-001 Intended Use Statement<\/span><span data-contrast=\"auto\">\uff08\u5167\u90e8\u6838\u51c6\u3001\u7248\u672c\u63a7\u7ba1\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">DOC-002 Indications for Use<\/span><span data-contrast=\"auto\">\uff08\u5c0d\u5916\u4e00\u81f4\u7248\u672c\uff0c\u7528\u65bc\u5c0d\u9f4a<\/span><span data-contrast=\"auto\">\u00a0submission\u00a0<\/span><span data-contrast=\"auto\">\u5167\u5bb9\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">DOC-003 Clinical Workflow &amp; Use Environment Map<\/span><span data-contrast=\"auto\">\uff08\u6a19\u8a3b\uff1a<\/span><span data-contrast=\"auto\">triage\/worklist<\/span><span data-contrast=\"auto\">\u3001<\/span><span data-contrast=\"auto\">concurrent\u00a0read<\/span><span data-contrast=\"auto\">\u3001<\/span><span data-contrast=\"auto\">second\u00a0read\u00a0<\/span><span data-contrast=\"auto\">\u7b49\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">MAT-001 Output Definition Matrix<\/span><span data-contrast=\"auto\">\uff08\u8f38\u5165<\/span><span data-contrast=\"auto\">\u2192<\/span><span data-contrast=\"auto\">\u8f38\u51fa<\/span><span data-contrast=\"auto\">\u2192<\/span><span data-contrast=\"auto\">\u81e8\u5e8a\u7528\u9014<\/span><span data-contrast=\"auto\">\u2192<\/span><span data-contrast=\"auto\">\u9a57\u8b49\u65b9\u6cd5\uff1b\u5c0d\u9f4a\u300c<\/span><span data-contrast=\"auto\">type of output<\/span><span data-contrast=\"auto\">\u300d\u8207<\/span><span data-contrast=\"auto\">\u00a0intended use<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">TPL-001 Labeling\/IFU Outline<\/span><span data-contrast=\"auto\">\uff08\u660e\u78ba\u5beb\u51fa<\/span><span data-contrast=\"auto\">\u00a0clinician oversight\u00a0<\/span><span data-contrast=\"auto\">\u8207\u9650\u5236\uff0c\u907f\u514d\u88ab\u89e3\u8b80\u6210<\/span><span data-contrast=\"auto\">\u00a0autonomous diagnosis<\/span><span data-contrast=\"auto\">\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>Bonus\uff1a\u4e09\u500b\u6700\u5e38\u898b\u8aa4\u5340\uff0c\u600e\u9ebc\u4e00\u53e5\u8a71\u6551\u56de\u4f86\uff1f\u00a0<\/strong><\/p>\n<p><strong>\u8aa4\u5340\u00a01\uff08\u60f3\u8d70\u00a0CADt\uff09\uff1a\u5beb\u300c\u53ef\u6a19\u8a18\u8166\u51fa\u8840\u4f4d\u7f6e\u300d\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u554f\u984c\u4e0d\u5728\u65bc\u4f60\u505a\u4e0d\u5230\uff0c\u800c\u662f\u9019\u53e5\u8a71\u628a\u4f60\u5f80<\/span><span data-contrast=\"auto\">\u00a0lesion-level marking\u00a0<\/span><span data-contrast=\"auto\">\u63a8\uff1b\u800c\u00a0<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\u00a0\u7684\u5178\u578b\u8f38\u51fa\u662f<\/span><span data-contrast=\"auto\">\u00a0case-level flag\/priority<\/span><span data-contrast=\"auto\">\uff0c\u901a\u5e38\u4e0d\u5b9a\u4f4d\u4e5f\u4e0d\u8a3a\u65b7\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4fee\u6b63\u7248\uff08<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\"> \u8a9e\u611f\uff09\uff1a<br \/>\n<\/span><span data-contrast=\"auto\">\u300c\u672c\u8edf\u9ad4\u7528\u65bc\u8fa8\u8b58\u7591\u4f3c<\/span><span data-contrast=\"auto\">\u00a0XXX\u00a0<\/span><span data-contrast=\"auto\">\u4e4b\u5f71\u50cf\u6aa2\u67e5\uff0c\u4e26\u900f\u904e\u901a\u77e5\/\u512a\u5148\u6392\u5e8f\u6a5f\u5236\u5354\u52a9\u81e8\u5e8a\u4eba\u54e1\u512a\u5148\u5be9\u95b1\u3002\u300d<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u8aa4\u5340\u00a02\uff1a\u5beb\u300cAutomatically diagnoses\u2026\u300d\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u9019\u6703\u8b93<\/span><span data-contrast=\"auto\">\u00a0reviewer\u00a0<\/span><span data-contrast=\"auto\">\u76f4\u89ba\u806f\u60f3\u5230<\/span><span data-contrast=\"auto\">\u00a0autonomous diagnosis<\/span><span data-contrast=\"auto\">\u3002\u4f60\u63d0\u4f9b\u7684\u53c3\u8003\u6a94\u5728\u00a0<\/span><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u7684\u5340\u5206\u4e0a\uff0c\u5176\u5be6\u4e00\u76f4\u5f37\u8abf\u300c<\/span><span data-contrast=\"auto\">aid<\/span><span data-contrast=\"auto\">\u300d\u300c<\/span><span data-contrast=\"auto\">support<\/span><span data-contrast=\"auto\">\u300d\u7684\u8a9e\u610f\uff0c\u800c\u4e0d\u662f\u300c\u53d6\u4ee3\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4fee\u6b63\u7248\uff08<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\u00a0\u8a9e\u611f\uff09\uff1a<\/span><br \/>\n<span data-contrast=\"auto\">\u300c\u672c\u8edf\u9ad4\u65e8\u5728\u6a19\u8a18\u7591\u4f3c\u75c5\u7076\u5340\u57df\uff0c\u8f14\u52a9\u53d7\u8a13\u4e4b\u5c08\u696d\u4eba\u54e1\u9032\u884c\u5075\u6e2c\u8207\u5224\u8b80\u3002\u300d<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u8aa4\u5340\u00a03\uff08\u5206\u5272\/\u91cf\u6e2c\uff09\uff1a\u5beb\u300c\u4f9b\u6cbb\u7642\u6c7a\u7b56\u300d\u4f46\u6c92\u5beb\u5c08\u696d\u5be9\u67e5\u8cac\u4efb\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u9019\u53e5\u4e0d\u662f\u4e0d\u80fd\u7528\uff0c\u4f46\u4f60\u9700\u8981\u628a\u8cac\u4efb\u5207\u5272\u5beb\u6e05\u695a\uff0c\u907f\u514d\u88ab\u7406\u89e3\u6210\u300c\u7cfb\u7d71\u76f4\u63a5\u4e0b\u6cbb\u7642\u7d50\u8ad6\u300d\u3002\u628a\u5b83\u6539\u6210\u300c\u63d0\u4f9b\u8f38\u5165\u300d\u300c\u9700<\/span><span data-contrast=\"auto\">\u00a0review\/edit<\/span><span data-contrast=\"auto\">\u300d\u901a\u5e38\u66f4\u5b89\u5168\uff0c\u4e5f\u66f4\u7b26\u5408\u8fd1\u5e74<\/span><span data-contrast=\"auto\">\u00a0cleared indications\u00a0<\/span><span data-contrast=\"auto\">\u7684\u8a9e\u611f\u8da8\u52e2\uff08\u5f37\u8abf<\/span><span data-contrast=\"auto\">\u00a0clinician-supervised uses<\/span><span data-contrast=\"auto\">\uff09\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u4e94\u3001\u7d50\u8a9e\uff1aIntended Use\u00a0\u662f\u5206\u985e\u7684\u8d77\u9ede\uff0c\u4e5f\u662f\u4f60\u6240\u6709\u8b49\u64da\u7684\u7e3d\u958b\u95dc\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">\u5728\u5f71\u50cf<\/span><span data-contrast=\"auto\">\u00a0AI\u00a0<\/span><span data-contrast=\"auto\">\u7684\u4e16\u754c\u88e1\uff0c\u4f60\u4e0d\u662f\u5148\u505a\u5b8c\u7522\u54c1\u518d\u627e\u6cd5\u898f\uff1b\u4f60\u662f\u5148\u7528<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u628a\u7522\u54c1\u300c\u5b9a\u7fa9\u6210\u4e00\u500b\u53ef\u88ab\u5206\u985e\u3001\u53ef\u88ab\u9a57\u8b49\u7684\u6771\u897f\u300d\u3002<\/span> <span data-contrast=\"auto\">FDA\u00a0<\/span><span data-contrast=\"auto\">\u5c0d\u00a0<\/span><span data-contrast=\"auto\">CADe<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADx<\/span><span data-contrast=\"auto\">\/<\/span><span data-contrast=\"auto\">CADt<\/span><span data-contrast=\"auto\">\u00a0\u7684\u5340\u5206\u91cd\u9ede\uff0c\u8aaa\u5230\u5e95\u5c31\u662f<\/span><span data-contrast=\"auto\">\u00a0intended use\u00a0<\/span><span data-contrast=\"auto\">\u8207<\/span><span data-contrast=\"auto\">\u00a0output type<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5982\u679c\u4f60\u9858\u610f\uff0c\u6211\u5011\u53ef\u4ee5\u628a\u4f60\u7684<\/span><span data-contrast=\"auto\">\u00a0Intended Use\u00a0<\/span><span data-contrast=\"auto\">\u9010\u53e5\u505a\u4e00\u6b21\u300c<\/span><span data-contrast=\"auto\">Reviewer Simulation<\/span><span data-contrast=\"auto\">\u300d\uff1a<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u5148\u4f9d\u4f60\u9810\u671f\u7684\u8f38\u51fa\uff08<\/span><span data-contrast=\"auto\">case-level flag vs ROI marking vs probability<\/span><span data-contrast=\"auto\">\uff09\u5c0d\u61c9\u5230\u8f03\u5408\u7406\u7684<\/span><span data-contrast=\"auto\">\u00a0product code\u00a0<\/span><span data-contrast=\"auto\">\u6876\u5b50\uff08\u4f8b\u5982<\/span><span data-contrast=\"auto\">\u00a0QAS\/POK\/QDQ\u00a0<\/span><span data-contrast=\"auto\">\u7b49\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u518d\u628a\u6bcf\u4e00\u53e5\u52d5\u8a5e\u8207\u9650\u5236\u689d\u6b3e\uff0c\u8abf\u6210\u300c\u4e0d\u6539\u529f\u80fd\u3001\u4f46\u964d\u4f4e\u88ab\u8aa4\u5206\u985e\u98a8\u96aa\u300d\u7684\u5beb\u6cd5<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><strong>\u82e5\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\u66f4\u591a\u8cc7\u8a0a\uff0c\u6b61\u8fce\u5bc4\u4fe1\u81f3Joseph.Shen@behealthventures.com\u00a0<\/strong><\/p>\n","protected":false},"featured_media":10682,"parent":0,"menu_order":0,"template":"","class_list":["post-10678","knowledge_base","type-knowledge_base","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/knowledge_base\/10678","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/knowledge_base"}],"about":[{"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/types\/knowledge_base"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/media\/10682"}],"wp:attachment":[{"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/media?parent=10678"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}