{"id":11417,"date":"2026-05-11T15:54:48","date_gmt":"2026-05-11T07:54:48","guid":{"rendered":"https:\/\/www.behealthventures.com\/?post_type=knowledge_base&p=11417"},"modified":"2026-05-11T15:54:48","modified_gmt":"2026-05-11T07:54:48","slug":"fda-%e5%af%a9%e6%9f%a5%e8%a6%96%e8%a7%92%ef%bd%9cai-%e9%86%ab%e7%99%82%e6%96%b0%e5%89%b5%e8%b5%b0-510k-%e9%82%84%e6%98%af-de-novo%ef%bc%9f%e4%b8%80%e5%bc%b5%e5%88%86%e9%a1%9e%e5%88%a4%e6%96%b7","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%e6%96%b0%e5%89%b5%e8%b5%b0-510k-%e9%82%84%e6%98%af-de-novo%ef%bc%9f%e4%b8%80%e5%bc%b5%e5%88%86%e9%a1%9e%e5%88%a4%e6%96%b7\/","title":{"rendered":"FDA \u5be9\u67e5\u8996\u89d2\uff5cAI \u91ab\u7642\u65b0\u5275\u8d70 510(k) \u9084\u662f De Novo\uff1f\u4e00\u5f35\u5206\u985e\u5224\u65b7\u6a39\u3001Predicate \u9078\u932f\u7684\u4ee3\u50f9\u8207 3 \u6bb5\u88dc\u6551\u7b56\u7565"},"content":{"rendered":"

\"\"<\/p>\n

\u6bd4\u7ffc\u751f\u91ab\u5275\u6295 \u6295\u8cc7\u66a8\u81e8\u5e8a\u7b56\u7565\u526f\u7e3d \u6c88\u4fe1\u7def<\/p>\n

AI SaMD \u65b0\u5275\u6700\u5e38\u8e29\u7684\u5751\uff0c\u4e0d\u662f\u6f14\u7b97\u6cd5\u4e0d\u5920\u5f37\uff0c\u800c\u662f\u5be9\u67e5\u8def\u5f91\u8d70\u932f\uff0c\u6216\u662f Predicate \u9078\u932f\u3002\u9019\u5169\u4ef6\u4e8b\u4e00\u65e6\u51fa\u932f\uff0c\u5f8c\u679c\u901a\u5e38\u4e0d\u662f\u591a\u88dc\u5e7e\u4efd\u8cc7\u6599\u800c\u5df2\uff0c\u800c\u662f\u8b93\u4e0a\u5e02\u6642\u7a0b\u5ef6\u5b95\u534a\u5e74\u4ee5\u4e0a\uff0c\u91cd\u5275\u8cc7\u91d1\u6d88\u8017\u901f\u5ea6\uff08burn rate\uff09\uff0c\u751a\u81f3\u5728\u4e0b\u4e00\u8f2a\u52df\u8cc7\u524d\u628a runway \u71d2\u5149\uff0c\u628a\u4f60\u903c\u9032\u4e00\u689d\u539f\u672c\u6c92\u6253\u7b97\u8d70\u7684 De Novo\u3002<\/p>\n

\u4ee5\u4e0b\u7528 FDA \u5be9\u67e5\u8a9e\u8a00\uff0c\u628a 510(k) \u8207 De Novo \u62c6\u6210\u53ef\u76f4\u63a5\u7528\u65bc\u5167\u90e8\u6c7a\u7b56\u7684\u6846\u67b6\uff0c\u4f9d\u5e8f\u8d70\u904e\u5206\u985e\u5224\u65b7\u3001Predicate \u98a8\u96aa\u3001\u9078\u932f\u4ee3\u50f9\u8207\u88dc\u6551\u6253\u6cd5\uff0c\u6700\u5f8c\u9644\u4e0a\u53ef\u76f4\u63a5\u8907\u88fd\u7684 Predicate \u7be9\u9078 Memo \u7bc4\u672c\u3002<\/p>\n

\u5148\u628a\u898f\u5247\u8b1b\u6e05\u695a\uff1a510(k) \u8207 De Novo \u7684\u672c\u8cea\u5dee\u7570<\/p>\n

1\uff09510(k)\uff1a\u4f60\u5728\u505a\u7684\u662f\u5be6\u8cea\u7b49\u6548\uff08Substantial Equivalence, SE\uff09<\/strong>
\n510(k) \u7684\u524d\u63d0\u662f\u4f60\u627e\u5f97\u5230\u4e00\u500b\u5408\u6cd5\u4e0a\u5e02\u4e14\u5df2\u6838\u51c6\u7684 Predicate device\uff0c\u4e26\u8b49\u660e\u4f60\u7684\u7522\u54c1\u8207\u5b83\u5728\u9810\u671f\u7528\u9014\uff08Intended Use\uff09\u76f8\u540c\uff0c\u4e14\u6280\u8853\u7279\u6027\u76f8\u4f3c\u6216\u53ef\u6bd4\uff0c\u6574\u9ad4\u5b89\u5168\u6709\u6548\u6027\u4e0d\u4f4e\u65bc Predicate\u3002<\/p>\n

\u9019\u689d\u8def\u5f91\u7684\u6838\u5fc3\u50f9\u503c\u5728\u65bc\u7bc0\u594f\u53ef\u63a7\u3002\u5b98\u65b9\u76ee\u6a19\u5be9\u67e5\u70ba 90 \u5929\uff0c\u5be6\u52d9\u5e73\u5747\u7d04 4 \u81f3 6 \u500b\u6708\uff0c\u8996\u88dc\u4ef6\u8f2a\u6b21\u8207\u7522\u54c1\u8907\u96dc\u5ea6\u800c\u5b9a\u3002\u5c31\u5e02\u5834\u73fe\u6cc1\u800c\u8a00\uff0c\u591a\u6578 AI\/ML SaMD \u6700\u7d42\u4ecd\u4ee5 510(k) \u70ba\u4e3b\u6d41\u8def\u5f91\uff0c\u5e38\u898b\u7d71\u8a08\u53ef\u9054 97% \u81f3 97.5%\u3002<\/p>\n

2\uff09De Novo\uff1a\u4f60\u5728\u505a\u7684\u662f\u5efa\u7acb\u65b0\u5206\u985e\u8207\u7279\u6b8a\u63a7\u5236\u63aa\u65bd\uff08Special Controls\uff09<\/strong>
\n\u7576\u4f60\u627e\u4e0d\u5230\u5408\u9069 Predicate\uff0c\u4f46\u7522\u54c1\u4ecd\u5c6c\u4f4e\u5230\u4e2d\u5ea6\u98a8\u96aa\uff08Class I \u6216 Class II\uff09\uff0cDe Novo \u7528\u4f86\u5efa\u7acb\u65b0\u7684\u5206\u985e\u8207\u7522\u54c1\u4ee3\u78bc\uff0c\u4e26\u63d0\u51fa FDA \u53ef\u63a5\u53d7\u7684\u7279\u6b8a\u63a7\u5236\u63aa\u65bd\uff08Special Controls\uff09\u3002<\/p>\n

\u9019\u689d\u8def\u5f91\u7684\u6838\u5fc3\u4ee3\u50f9\u5728\u65bc\u8b49\u64da\u5bc6\u5ea6\u66f4\u9ad8\uff0c\u6642\u9593\u4e5f\u66f4\u9577\u3002\u5b98\u65b9\u76ee\u6a19\u70ba 150 \u81f3 180 \u5929\uff0c\u5be6\u52d9\u5e73\u5747\u7d04 7 \u81f3 9 \u500b\u6708\uff0c\u9047\u5230\u722d\u9ede\u6642\u53ef\u80fd\u5ef6\u9577\u81f3 12 \u500b\u6708\u3002\u5be6\u4f5c\u4e0a\uff0c\u4f60\u5fc5\u9808\u66f4\u50cf\u81ea\u5df1\u7576\u81ea\u5df1\u7684 Predicate\uff0c\u7368\u7acb\u8b49\u660e\u5b89\u5168\u8207\u6709\u6548\u6027\uff0c\u63d0\u4f9b\u81e8\u5e8a\u6578\u64da\u6216\u771f\u5be6\u4e16\u754c\u8b49\u64da\uff08Real World Evidence, RWE\uff09\uff0c\u57f7\u884c\u98a8\u96aa\u6548\u76ca\u5206\u6790\uff08risk benefit\uff09\uff0c\u4e26\u63d0\u51fa\u4f8b\u5982\u9810\u5b9a\u8b8a\u66f4\u63a7\u5236\u8a08\u756b\uff08Predetermined Change Control Plan, PCCP\uff09\u7b49\u53ef\u6cbb\u7406\u66f4\u65b0\u7684\u63a7\u5236\u63aa\u65bd\u3002<\/p>\n

\u4e8c\u3001\u4e00\u5f35\u5206\u985e\u5224\u65b7\u6a39\uff1a\u4f60\u5230\u5e95\u8a72\u8d70\u54ea\u4e00\u689d<\/strong>
\n\u628a\u8def\u5f91\u9078\u64c7\u6536\u6582\u6210\u4e09\u500b\u5224\u65b7\u9ede\uff0c\u9806\u8457\u8d70\u5c31\u4e0d\u5bb9\u6613\u504f\u822a\u3002<\/p>\n

\u5224\u65b7\u9ede 1\uff1aIntended Use \u80fd\u4e0d\u80fd\u9010\u5b57\u5c0d\u9f4a\u65e2\u6709\u6838\u51c6\u7522\u54c1
\n510(k) \u6700\u6015\u7684\u4e0d\u662f\u4f60\u529f\u80fd\u66f4\u5f37\uff0c\u800c\u662f\u4f60\u5728 Intended Use \u4e0a\u770b\u8d77\u4f86\u5dee\u4e0d\u591a\u4f46\u5176\u5be6\u4e0d\u540c\u3002\u53ea\u8981 Intended Use \u5c0d\u4e0d\u8d77\u4f86\uff0c\u4f60\u518d\u600e\u9ebc\u6bd4\u6027\u80fd\uff0cFDA \u4e5f\u5f88\u96e3\u8b93\u4f60\u7528 SE \u7684\u908f\u8f2f\u8d70\u5b8c 510(k)\u3002<\/p>\n

\u5224\u65b7\u9ede 2\uff1a\u662f\u5426\u5b58\u5728\u53ef\u9632\u5b88\u7684 Predicate
\n\u53ef\u9632\u5b88\u4e0d\u7b49\u65bc\u8cc7\u6599\u5eab\u6488\u5230\u4e00\u500b K number\u3002\u53ef\u9632\u5b88\u4ee3\u8868\u4f60\u7684\u5019\u9078 Predicate \u80fd\u540c\u6642\u6eff\u8db3\u5e7e\u500b\u689d\u4ef6\uff1aIntended Use \u5c0d\u5f97\u8d77\u4f86\uff0c\u6280\u8853\u7279\u6027\u76f8\u4f3c\u6216\u53ef\u7528\u6e2c\u8a66\u88dc\u9f4a\u7b49\u6548\uff0c\u6709\u516c\u958b\u8cc7\u6599\u6216\u6587\u737b\u53ef\u5efa\u7acb\u6548\u80fd\u57fa\u6e96\uff08baseline\uff09\uff0c\u4e14\u6c92\u6709\u5df2\u77e5\u5b89\u5168\u7591\u616e\u6216\u91cd\u5927\u8a2d\u8a08\u5305\u88b1\u3002<\/p>\n

\u5224\u65b7\u9ede 3\uff1a\u6280\u8853\u5dee\u7570\u6703\u4e0d\u6703\u9020\u6210\u65b0\u7684\u5b89\u5168\u6709\u6548\u6027\u554f\u984c
\n\u53ea\u8981 FDA \u8a8d\u70ba\u8f38\u51fa\u5f62\u5f0f\u5dee\u7570\uff0c\u4f8b\u5982 heatmap\uff0c\u6216\u4f7f\u7528\u5834\u666f\u5dee\u7570\uff0c\u6216\u6027\u80fd\u6307\u6a19\u4e0d\u53ef\u6bd4\u800c\u5c0e\u81f4\u65b0\u7684\u554f\u984c\uff0c\u4f60\u5c31\u5f88\u5bb9\u6613\u6536\u5230\u88dc\u4ef6\u4fe1\uff08Additional Information, AI\uff09\uff0c\u751a\u81f3\u88ab\u5224\u5b9a\u975e\u5be6\u8cea\u7b49\u6548\uff08Not Substantially Equivalent, NSE\uff09\uff0c\u6700\u5f8c\u88ab\u8feb\u6539\u9053\u3002<\/p>\n

\u4e09\u3001Predicate \u600e\u9ebc\u627e\u624d\u9632\u5b88\u5f97\u4f4f\uff1aFDA \u6700\u5728\u610f\u7684 4 \u689d Best Practices<\/strong>
\nPredicate \u5de5\u4f5c\u5efa\u8b70\u62c6\u6210\u5169\u6b65\uff0c\u5148\u627e\u5019\u9078\uff0c\u518d\u7be9\u5019\u9078\u3002<\/p>\n

\u7b2c\u4e00\u6b65\uff1a\u627e\u5019\u9078\uff08product code \u52a0\u95dc\u9375\u5b57\uff09
\n\u53ef\u5f9e FDA 510(k) database\uff08\u542b AccessGUDID\uff09\u8207\u5b98\u65b9 AI\/ML device \u6e05\u55ae\u8457\u624b\uff0c\u7528 product code \u52a0\u95dc\u9375\u5b57\u7e2e\u5c0f\u7bc4\u570d\u3002\u5be6\u52d9\u4e0a\u901a\u5e38\u512a\u5148\u5c0b\u627e\u8fd1 2 \u81f3 3 \u5e74\u5728\u7f8e\u570b\u6838\u51c6\u7684\u7522\u54c1\uff0c\u8f03\u8cbc\u8fd1\u73fe\u884c\u6a19\u6e96\uff0c\u540c\u6642\u907f\u514d\u628a\u5927\u91cf\u6642\u9593\u8017\u5728\u904e\u5ea6 legacy \u7684\u6838\u51c6\u54c1\u4e0a\u3002<\/p>\n

\u7b2c\u4e8c\u6b65\uff1a\u7be9\u5019\u9078\uff08FDA 2023 \u7684 4 Best Practices\uff09<\/p>\n

\u7b2c\u4e00\uff0c\u8fd1\u671f\u6838\u51c6\uff08Recent clearance\uff09\uff0c\u512a\u5148\u8fd1 2 \u5e74\u5167\u6838\u51c6\u7684\u7522\u54c1\u3002\u7b2c\u4e8c\uff0c\u7121\u5df2\u77e5\u5b89\u5168\u554f\u984c\uff08No known safety issues\uff09\uff0c\u900f\u904e MAUDE\u3001recall\u3001warning letter \u7b49\u516c\u958b\u8cc7\u8a0a\u78ba\u8a8d\u6c92\u6709\u91cd\u5927\u8b66\u8a0a\u3002\u7b2c\u4e09\uff0c\u5df2\u8b49\u5be6\u6548\u80fd\uff08Demonstrated performance\uff09\uff0c\u5177\u5099\u516c\u958b\u6587\u737b\u6216\u81e8\u5e8a\u8cc7\u6599\uff0c\u8db3\u4ee5\u5efa\u7acb\u5b89\u5168\u8207\u6709\u6548\u6027\u57fa\u6e96\u3002\u7b2c\u56db\uff0c\u7121\u91cd\u5927\u8a2d\u8a08\u554f\u984c\uff08No major design issues\uff09\uff0c\u907f\u958b\u5df2\u77e5\u8a2d\u8a08\u7f3a\u9677\u6216\u9ad8\u5ea6\u722d\u8b70\u7684\u7522\u54c1\u8a2d\u8a08\u3002
\n\u5169\u500b\u52a0\u5206\u4f46\u5e38\u88ab\u8aa4\u89e3\u7684\u91cd\u9ede<\/p>\n

Predicate \u4e0d\u4e00\u5b9a\u8981\u662f AI\u3002\u4f60\u53ef\u4ee5\u4f7f\u7528\u50b3\u7d71\u975e AI \u8edf\u9ad4\u4f5c\u70ba Predicate\uff0c\u53ea\u8981\u80fd\u8b49\u660e AI \u8f38\u51fa\u7684\u7d50\u679c\u5728\u81e8\u5e8a\u610f\u7fa9\u4e0a\u76f8\u7576\uff0c\u6216\u80fd\u7528\u6e2c\u8a66\u628a\u53ef\u6bd4\u6027\u8aaa\u6e05\u695a\u3002\u53e6\u4e00\u500b\u662f\u907f\u514d\u6df7\u7528 Predicate\uff08split predicates\uff09\u3002\u6df7\u7528\u591a\u500b Predicate \u4f86\u62fc\u6e4a\u7b49\u6548\u6703\u8b93\u8ad6\u8b49\u8b8a\u8106\u5f31\uff0cFDA \u4e0d\u504f\u597d\u6b64\u4f5c\u6cd5\uff0cAI\/ML SaMD \u5be6\u52d9\u4e0a\u4e5f\u591a\u4ee5\u55ae\u4e00\u4e3b Predicate \u70ba\u4e3b\u3002<\/p>\n

\u56db\u3001Predicate \u9078\u932f\u7684\u4ee3\u50f9\uff1a\u4e0d\u662f\u9000\u4ef6\u800c\u5df2\uff0c\u662f\u88ab\u6539\u9053\u8207\u7bc0\u594f\u5d29\u58de<\/strong><\/p>\n

\u5728 AI SaMD \u9818\u57df\uff0cPredicate \u722d\u8b70\u662f\u9ad8\u983b\u4e8b\u4ef6\u3002\u5e38\u898b\u8cc7\u6599\u6307\u51fa AI SaMD \u9762\u81e8 FDA \u5224\u5b9a NSE \u7684\u6bd4\u7387\u53ef\u9ad8\u9054 25%\uff0c\u9078\u932f Predicate \u662f\u6700\u5178\u578b\u4e5f\u6700\u81f4\u547d\u7684\u539f\u56e0\u4e4b\u4e00\u3002<\/p>\n

\u5178\u578b\u640d\u5931\u901a\u5e38\u6709\u4e09\u5c64\u3002\u7b2c\u4e00\u5c64\u662f\u5be9\u67e5\u5ef6\u9072\uff0c\u4f60\u6703\u5148\u6536\u5230\u88dc\u4ef6\u4fe1\uff08AI\uff09\uff0c\u4f86\u56de\u62c9\u92f8\u5f8c\u8b93\u4e0a\u5e02\u6642\u7a0b\u5ef6\u9072\u6578\u500b\u6708\u3002\u7b2c\u4e8c\u5c64\u662f\u91cd\u5de5\u6210\u672c\uff0c\u88dc\u6e2c\u3001\u88dc\u6587\u4ef6\u3001\u88dc\u81e8\u5e8a\u8cc7\u6599\uff0c\u5f80\u5f80\u76f4\u63a5\u591a\u71d2\u4e00\u7b46\uff0c\u5e38\u898b\u53ef\u9054\u4e94\u842c\u7f8e\u5143\u7b49\u7d1a\u751a\u81f3\u66f4\u9ad8\u3002\u7b2c\u4e09\u5c64\u662f\u6700\u7cdf\u60c5\u5883\uff0cNSE \u5f8c\u88ab\u8feb\u64a4\u56de\u91cd\u63d0\uff0c\u6216\u76f4\u63a5\u8f49\u5411 De Novo\uff0c\u7b49\u65bc\u628a 510(k) \u524d\u671f\u6295\u5165\u7576\u6210\u5b78\u8cbb\uff0c\u9084\u8981\u91cd\u5efa\u8b49\u64da\u7b56\u7565\u8207\u7522\u54c1\u6558\u4e8b\u3002<\/p>\n

\u5e38\u898b\u6559\u8a13\u5305\u62ec\u5169\u985e\u3002\u7b2c\u4e00\u985e\u662f\u5f71\u50cf AI \u9078\u7528\u8f03\u820a\u4e14\u975e ML \u7684\u8edf\u9ad4\u7576 Predicate\uff0c\u56e0\u6df1\u5ea6\u5b78\u7fd2\u8f38\u51fa\u8207\u5448\u73fe\u65b9\u5f0f\u5dee\u7570\uff0c\u4e0d\u88ab\u8996\u70ba\u7b49\u6548\u800c\u88ab\u5224 NSE\uff0c\u8f49\u8d70 De Novo \u5f8c\u591a\u8017\u8cbb\u6578\u6708\u3002\u7b2c\u4e8c\u985e\u662f\u8de8\u75be\u75c5\u6216\u8de8\u89e3\u5256\u90e8\u4f4d\u786c\u5957 Predicate\uff0c\u4f8b\u5982\u5fc3\u81df\u8a3a\u65b7 AI \u8aa4\u7528\u4e2d\u98a8 AI \u7576 Predicate\uff0c\u56e0\u89e3\u5256\u90e8\u4f4d\u8207\u6548\u80fd\u6307\u6a19\u843d\u5dee\u904e\u5927\u88ab\u8981\u6c42\u88dc\u4ef6\uff0c\u6700\u7d42\u4ecd\u88ab\u8feb\u64a4\u56de\u91cd\u63d0\u3002<\/p>\n

\u4e94\u3001\u4e09\u6bb5\u88dc\u6551\u7b56\u7565\uff1a\u5361\u5728\u54ea\u4e00\u6bb5\uff0c\u5c31\u7528\u54ea\u4e00\u5957\u6253\u6cd5<\/strong><\/p>\n

A \u6bb5\uff1a\u9084\u6c92\u9001\u4ef6\u524d\uff08\u6210\u672c\u6700\u4f4e\uff0c\u56de\u5831\u6700\u9ad8\uff09
\n\u5f37\u70c8\u5efa\u8b70\u5728\u6b63\u5f0f\u9001\u4ef6\u524d 1 \u81f3 2 \u500b\u6708\u63d0\u4ea4 Q Submission\uff08Q Sub\uff09\u3002\u628a Intended Use \u7684\u9010\u5b57\u5c0d\u9f4a\u7b56\u7565\u3001Predicate \u9078\u64c7\u7406\u7531\uff08\u7528 4 Best Practices \u67b6\u69cb\uff09\u3001\u4ee5\u53ca\u5dee\u7570\u9ede\u8207\u6e2c\u8a66\u88dc\u5f37\u8a08\u756b\u5148\u4ea4\u7d66 FDA \u770b\uff0c\u53d6\u5f97\u66f8\u9762\u610f\u898b\u80fd\u5927\u5e45\u964d\u4f4e NSE \u98a8\u96aa\uff0c\u4e5f\u80fd\u907f\u514d\u5728\u5be9\u67e5\u4e2d\u9014\u624d\u767c\u73fe\u81ea\u5df1\u7ad9\u932f\u968a\u3002<\/p>\n

B \u6bb5\uff1a\u5df2\u9032\u5be9\u67e5\uff0cFDA \u958b\u59cb\u8cea\u7591 Predicate\uff0c\u4f46\u5c1a\u672a NSE
\n\u76ee\u6a19\u662f\u6b62\u8840\u8207\u7a69\u4f4f SE \u8ad6\u8b49\u3002\u7b2c\u4e00\uff0c\u555f\u7528\u5099\u7528 Predicate\uff0c\u5982\u679c\u4f60\u6709\u4e8b\u5148\u6e96\u5099\u7b2c\u4e8c\u9806\u4f4d\u5019\u9078\uff0c\u9019\u6642\u5019\u53ef\u4ee5\u5feb\u901f\u5207\u63db\uff0c\u907f\u514d\u5728\u540c\u4e00\u500b\u932f\u8aa4 Predicate \u4e0a\u8d8a\u88dc\u8d8a\u6df1\u3002\u7b2c
\n\u4e8c\uff0c\u88dc\u5f37\u8b49\u64da\u968e\u5c64\uff08hierarchy of evidence\uff09\uff0c\u7528 FDA guidance\u3001\u5171\u8b58\u6a19\u6e96\u8207\u540c\u884c\u8a55\u5be9\u6587\u737b\u5efa\u7acb baseline\uff0c\u518d\u7528\u91d1\u6a19\u6e96\u5c0d\u7167\u6e2c\u8a66\u628a\u7b49\u6548\u8ad6\u8b49\u8b8a\u6210\u53ef\u91cf\u5316\u7d50\u8ad6\u3002\u7b2c\u4e09\uff0c\u91cd\u65b0\u6574\u7406\u5dee\u7570\u9ede\uff0c\u628a\u5dee\u7570\u9ede\u6539\u5beb\u6210\u53ef\u6e2c\u8a66\u7684 claim\uff0c\u8b93\u5be9\u67e5\u7126\u9ede\u56de\u5230\u4f60\u80fd\u63a7\u5236\u7684 endpoints \u4e0a\u3002<\/p>\n

C \u6bb5\uff1a\u5df2\u88ab\u5224 NSE\uff0c\u6216\u4f60\u5224\u65b7\u518d\u6490\u4e5f\u6490\u4e0d\u4f4f
\n\u6b64\u6642\u53ea\u5269\u5169\u689d\u8def\u3002\u7b2c\u4e00\u662f\u91cd\u63d0\u65b0\u7684 510(k)\uff0c\u63a1\u7528\u5b8c\u5168\u4e0d\u540c\u7684 Predicate \u91cd\u65b0\u9001\u4ef6\uff0c\u4e26\u628a SE \u8ad6\u8b49\u5f9e Intended Use \u5230 testing plan \u91cd\u65b0\u91d8\u7262\u3002\u7b2c\u4e8c\u662f\u679c\u65b7\u8f49 De Novo\uff0c\u7576\u5e02\u5834\u4e0a\u78ba\u5be6\u4e0d\u5b58\u5728\u7b49\u6548\u7522\u54c1\u6642\uff0c\u786c\u62d7 SE \u53ea\u6703\u5ef6\u9577 burn rate\uff0c\u6539\u8d70 De Novo \u5efa\u7acb\u5c08\u5c6c\u5206\u985e\u53cd\u800c\u66f4\u7b26\u5408\u8cc7\u6e90\u914d\u7f6e\u3002<\/p>\n

\u516d\u3001De Novo \u4e0d\u662f\u6bd4\u8f03\u96e3\u7684 510(k)\uff0c\u800c\u662f\u53e6\u4e00\u7a2e\u8b49\u64da\u6230\u00a0<\/strong><\/p>\n

\u6c92\u6709 Predicate \u4ee3\u8868\u4f60\u5f97\u7528\u66f4\u5b8c\u6574\u7684\u8cc7\u6599\u8207\u63a7\u5236\u63aa\u65bd\u7368\u7acb\u8b49\u660e\u5b89\u5168\u6709\u6548\uff0c\u4e26\u63d0\u51fa Special Controls\u3002De Novo \u8b49\u64da\u5305\u901a\u5e38\u5305\u542b\u66f4\u5b8c\u6574\u7684\u81e8\u5e8a\u6578\u64da\u6216\u591a\u4e2d\u5fc3 RWE\uff0c\u7368\u7acb\u4e14\u91cf\u5316\u7684\u98a8\u96aa\u6548\u76ca\u5206\u6790\uff08risk benefit\uff09\uff0c\u4ee5\u53ca\u7279\u6b8a\u63a7\u5236\u63aa\u65bd\u63d0\u6848\u3002\u5c0d AI\/ML \u7522\u54c1\u800c\u8a00\uff0cPCCP \u5f80\u5f80\u662f\u95dc\u9375\uff0c\u56e0\u70ba\u5b83\u7528\u4f86\u8b49\u660e\u672a\u4f86\u6a21\u578b\u8b8a\u66f4\u53ef\u4ee5\u88ab\u5b89\u5168\u7ba1\u7406\uff0c\u8b93\u7522\u54c1\u66f4\u65b0\u7b56\u7565\u4e0d\u81f3\u65bc\u8b8a\u6210\u76e3\u7ba1\u9ed1\u6d1e\u3002<\/p>\n

\u4e03\u3001\u53ef\u76f4\u63a5\u8907\u88fd\u7684 Predicate \u7be9\u9078 Memo \u7bc4\u672c<\/strong>
\n\u628a\u4e0b\u9762\u9019\u4efd Memo \u6a21\u677f\u4ea4\u7d66\u5718\u968a\uff0c\u901a\u5e38\u6bd4\u53e3\u982d\u8a0e\u8ad6\u66f4\u5feb\u5f62\u6210\u5171\u8b58\uff0c\u4e5f\u66f4\u5bb9\u6613\u5728 Q Sub \u8207 510(k) \u6587\u4ef6\u4e2d\u91cd\u7528\u3002<\/p>\n

\u7b2c\u4e00\u90e8\u5206\u662f Device \u6982\u8ff0\u3002\u7528\u4e09\u53e5\u8a71\u8aaa\u6e05\u695a\u7522\u54c1\u540d\u7a31\uff08Product\uff09\uff0c\u9810\u671f\u7528\u9014\u8349\u6848\uff08Indication or Intended Use\uff09\uff0c\u4ee5\u53ca\u81e8\u5e8a\u5de5\u4f5c\u6d41\u7a0b\uff08clinical workflow\uff09\uff0c\u6e05\u695a\u63cf\u8ff0\u8f38\u5165\u8cc7\u6599\u3001\u6f14\u7b97\u6cd5\u8f38\u51fa\u3001\u91ab\u5e2b\u6c7a\u7b56\u4f4d\u7f6e\u4e09\u8005\u7684\u95dc\u4fc2\u3002<\/p>\n

\u7b2c\u4e8c\u90e8\u5206\u662f\u5019\u9078 Predicate \u6e05\u55ae\u3002\u81f3\u5c11\u5217\u51fa\u4e09\u500b\u5019\u9078\u4e26\u9010\u4e00\u8a55\u4f30\u3002\u5148\u505a\u4e00\u81f4\u6027\u6aa2\u6838\uff0c\u78ba\u8a8d Intended Use \u662f\u5426\u53ef\u9010\u53e5\u5c0d\u9f4a\uff0c\u89e3\u5256\u90e8\u4f4d\u3001\u65cf\u7fa4\u3001\u4f7f\u7528\u8005\u662f\u5426\u4e00\u81f4\u3002\u518d\u505a\u6280\u8853\u53ef\u6bd4\u6027\u6aa2\u6838\uff0c\u78ba\u8a8d\u8f38\u51fa\u578b\u614b\u662f\u5426\u4e00\u81f4\uff0c\u5305\u542b heatmap\u3001triage \u7b49\u5448\u73fe\u65b9\u5f0f\uff0c\u4e26\u78ba\u8a8d\u6027\u80fd\u6307\u6a19\u662f\u5426\u53ef\u6bd4\uff0c\u4f8b\u5982 sensitivity\u3001specificity\u3001AUC\u3002\u63a5\u8457\u7528 4 Best Practices \u505a\u5feb\u901f\u9ad4\u6aa2\uff0c\u78ba\u8a8d\u662f\u5426\u8fd1 2 \u5e74\u6838\u51c6\uff0cMAUDE \u662f\u5426\u4e7e\u6de8\uff0c\u662f\u5426\u6709\u516c\u958b\u8cc7\u6599\u652f\u6301\u6548\u80fd\uff0c\u6709\u7121\u91cd\u5927\u8a2d\u8a08\u554f\u984c\u3002\u6700\u5f8c\u5beb\u98a8\u96aa\u8a3b\u8a18\uff0c\u82e5\u9700\u8981\u7b2c\u4e8c\u500b Predicate \u624d\u80fd\u88dc\u9f4a\u8ad6\u8b49\uff0c\u52d9\u5fc5\u76f4\u63a5\u6a19\u8a18\u70ba\u9ad8\u98a8\u96aa\uff0c\u82e5\u5019\u9078\u70ba\u975e AI Predicate\uff0c\u5247\u6e05\u695a\u5217\u51fa\u7b49\u6548\u8b49\u64da\u7b56\u7565\u8207\u5c0d\u7167\u6e2c\u8a66\u8a2d\u8a08\u3002<\/p>\n

\u7b2c\u4e09\u90e8\u5206\u662f\u5099\u63f4\u7b56\u7565\u3002\u5beb\u660e Primary Predicate \u8207 Backup Predicate\uff0c\u5217\u51fa\u5dee\u7570\u9ede\u6e05\u55ae\uff08delta list\uff09\u8207\u5c0d\u61c9\u7684 testing matrix\uff0c\u4e26\u88dc\u4e0a hierarchy of evidence \u8a08\u756b\uff0c\u8aaa\u660e\u82e5 Predicate \u516c\u958b\u8cc7\u6599\u4e0d\u8db3\uff0c\u4f60\u6253\u7b97\u5f15\u7528\u54ea\u4e9b\u6587\u737b\u3001\u5171\u8b58\u6a19\u6e96\u6216\u65e2\u6709\u8cc7\u6599\u5efa\u7acb baseline\u3002<\/p>\n

\u7b2c\u56db\u90e8\u5206\u662f Q Sub \u8a08\u756b\u3002\u586b\u4e0a\u9810\u8a08\u9001\u4ef6\u6642\u9593\uff0c\u5efa\u8b70\u5b9a\u5728\u6b63\u5f0f\u9001\u4ef6\u524d 1 \u81f3 2 \u500b\u6708\uff0c\u540c\u6642\u5217\u51fa\u4f60\u60f3\u5f9e FDA \u62ff\u5230\u7684\u7d50\u8ad6\u53e5\uff0c\u4f8b\u5982 Predicate \u63a5\u53d7\u5ea6\u3001classification \u63a5\u53d7\u5ea6\u3001testing plan \u63a5\u53d7\u5ea6\u3002<\/p>\n

\u7b2c\u4e94\u90e8\u5206\u662f\u8cc7\u6e90\u8207\u6642\u7a0b\u9810\u8b66\u3002\u4f30\u7b97\u6e96\u5099\u6210\u672c\uff0c\u5305\u542b\u984d\u5916\u6e2c\u8a66\u3001\u8cc7\u6599\u53d6\u5f97\u3001\u5916\u90e8\u81e8\u5e8a\u6216\u7d71\u8a08\u652f\u63f4\u3002\u4e26\u660e\u78ba\u5beb\u51fa\u6700\u5dee\u60c5\u5883\uff08worst case scenario\uff09\u7684\u885d\u64ca\u8a55\u4f30\uff0c\u4f8b\u5982\u82e5\u906d NSE \u800c\u8f49 De Novo\uff0c\u4e0a\u5e02\u6642\u9593\u53ef\u80fd\u589e\u52a0 6 \u81f3 9 \u500b\u6708\uff0c\u5c0d burn rate \u8207\u52df\u8cc7\u7bc0\u594f\u7684\u5177\u9ad4\u5f71\u97ff\u3002<\/p>\n

\u7d50\u8a9e<\/strong>
\n\u5f9e\u6295\u8cc7\u8207\u7d93\u71df\u7bc0\u594f\u4f86\u770b\uff0c510(k) \u8207 De Novo \u7684\u9078\u64c7\uff0c\u672c\u8cea\u662f\u4e00\u984c\u91cc\u7a0b\u7891\u8207\u73fe\u91d1\u6d41\u7ba1\u7406\u984c\u3002510(k) \u7684\u901f\u5ea6\u7d05\u5229\u5efa\u7acb\u5728\u5169\u500b\u524d\u63d0\uff1aIntended Use \u5fc5\u9808\u80fd\u9010\u5b57\u5c0d\u9f4a\uff0cSE \u5fc5\u9808\u80fd\u88ab\u91cf\u5316\u8b49\u64da\u7a69\u7a69\u652f\u6490\u3002\u53ea\u8981 Predicate \u7ad9\u4e0d\u4f4f\u8173\uff0c\u88dc\u4ef6\u8f2a\u6b21\u4e00\u62c9\u9577\uff0c\u6642\u7a0b\u4e0d\u78ba\u5b9a\u6027\u5c31\u6703\u7acb\u523b\u53cd\u6620\u5728 burn rate\u3001\u5546\u52d9\u8ac7\u5224\u8207\u52df\u8cc7\u4f30\u503c\u4e0a\uff0c\u751a\u81f3\u5728\u4e0b\u4e00\u8f2a\u52df\u8cc7\u524d\u628a runway \u71d2\u5230\u81e8\u754c\u9ede\u3002<\/p>\n

\u76f8\u5c0d\u5730\uff0cDe Novo \u7684\u5275\u65b0\u7d05\u5229\u4e0d\u5728\u65bc\u300c\u66f4\u96e3\u300d\u6216\u300c\u66f4\u9177\u300d\uff0c\u800c\u5728\u65bc\u4f60\u6709\u6a5f\u6703\u5efa\u7acb product code \u8207 Special Controls\uff0c\u66ff\u81ea\u5df1\u548c\u672a\u4f86\u540c\u985e\u7522\u54c1\u5283\u5b9a\u898f\u5247\u3002\u4f46\u9019\u689d\u8def\u7684\u4ee3\u50f9\u662f\u66f4\u9ad8\u7684\u8b49\u64da\u5bc6\u5ea6\u8207\u66f4\u56b4\u8b39\u7684\u98a8\u96aa\u6cbb\u7406\uff0c\u7279\u5225\u662f PCCP \u8207\u6301\u7e8c\u76e3\u6e2c\u6a5f\u5236\u5fc5\u9808\u53ef\u57f7\u884c\u4e14\u53ef\u88ab\u7a3d\u6838\u3002<\/p>\n

\u6700\u52d9\u5be6\u7684\u7b56\u7565\u662f\u628a\u4e0d\u78ba\u5b9a\u6027\u524d\u79fb\uff0c\u7528 Q Sub \u5728\u9001\u4ef6\u524d\u5148\u628a\u5206\u985e\u8207 Predicate \u9396\u5b9a\uff0c\u8b93\u516c\u53f8\u628a\u6709\u9650\u8cc7\u6e90\u7528\u5728\u6700\u6709\u6a5f\u7387\u8f49\u6210\u6838\u51c6\u8207\u71df\u6536\u7684\u8b49\u64da\u4e0a\uff0c\u907f\u514d\u5728\u5be9\u67e5\u4e2d\u9014\u624d\u88ab\u8feb\u6539\u9053\uff0c\u8b93\u6574\u500b\u7522\u54c1\u8207\u8cc7\u672c\u7bc0\u594f\u4e00\u8d77\u5931\u901f\u3002<\/p>\n

\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":11418,"parent":0,"menu_order":0,"template":"","class_list":["post-11417","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\/11417","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\/11418"}],"wp:attachment":[{"href":"https:\/\/behealthventures.com\/zh-hant\/wp-json\/wp\/v2\/media?parent=11417"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}