{"id":11423,"date":"2026-05-11T15:54:48","date_gmt":"2026-05-11T07:54:48","guid":{"rendered":"https:\/\/www.behealthventures.com\/knowledge_base\/fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%e3%81%a7%e8%80%83%e3%81%88%e3%82%8b%ef%bd%9cai%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%af510k%e3%81%8bde-novo%e3%81%8b-fda%e5%af%a9%e6%9f%bb\/"},"modified":"2026-05-11T16:15:04","modified_gmt":"2026-05-11T08:15:04","slug":"fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%e3%81%a7%e8%80%83%e3%81%88%e3%82%8b%ef%bd%9cai%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%af510k%e3%81%8bde-novo%e3%81%8b-fda%e5%af%a9%e6%9f%bb","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/ja\/knowledge_base\/fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%e3%81%a7%e8%80%83%e3%81%88%e3%82%8b%ef%bd%9cai%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%af510k%e3%81%8bde-novo%e3%81%8b-fda%e5%af%a9%e6%9f%bb\/","title":{"rendered":"FDA\u5be9\u67fb\u306e\u8996\u70b9\u3067\u8003\u3048\u308b\uff5cAI\u533b\u7642\u6a5f\u5668\u306f510(k)\u304bDe Novo\u304b FDA\u5be9\u67fb\u3067\u5931\u6557\u3057\u306a\u3044\u305f\u3081\u306e\u5224\u65ad\u30d5\u30ed\u30fc\u3068\u6226\u7565\u6574\u7406"},"content":{"rendered":"

\"\"<\/p>\n

BE Health Ventures<\/span>
\n\u6295\u8cc7\u30fb\u81e8\u5e8a\u6226\u7565\u62c5\u5f53 \u526f\u7dcf\u7d4c\u7406\u3000\u6c88\u4fe1\u7def<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>AI\u00a0SaMD<\/span>\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u304c\u6700\u3082\u9665\u308a\u3084\u3059\u3044\u843d\u3068\u3057\u7a74\u306f\u3001\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u6027\u80fd\u305d\u306e\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u30eb\u30fc\u30c8\u306e\u9078\u629e\u30df\u30b9\u3084Predicate\u306e\u8aa4\u8a2d\u5b9a\u306b\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u3092\u8aa4\u308b\u3068\u3001\u305d\u306e\u5f71\u97ff\u306f\u5358\u306a\u308b\u8ffd\u52a0\u8cc7\u6599\u306e\u63d0\u51fa\u3067\u306f\u53ce\u307e\u308a\u307e\u305b\u3093\u3002\u4e0a\u5e02\u307e\u3067\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u534a\u5e74\u4ee5\u4e0a\u9045\u5ef6\u3057\u3001\u8cc7\u91d1\u6d88\u8cbb\u306f\u6025\u6fc0\u306b\u60aa\u5316\u3001\u6700\u60aa\u306e\u5834\u5408\u306b\u306f\u6b21\u56de\u306e\u8cc7\u91d1\u8abf\u9054\u524d\u306b\u8cc7\u91d1\u3092\u4f7f\u3044\u5207\u3063\u3066\u3057\u307e\u3044\u3001\u5f53\u521d\u60f3\u5b9a\u3057\u3066\u3044\u306a\u304b\u3063\u305fDe Novo\u30eb\u30fc\u30c8\u3078\u306e\u8ee2\u63db\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u308b\u30b1\u30fc\u30b9\u3082\u5c11\u306a\u304f\u3042\u308a\u307e\u305b\u3093\u3002<\/span>\u00a0<\/span><\/p>\n

\u672c\u7de8\u3067\u306f\u3001FDA\u306e\u5be9\u67fb\u5b9f\u52d9\u306b\u57fa\u3065\u304d\u3001510(k)\u3068De Novo\u306e\u9078\u629e\u3092\u793e\u5185\u3067\u518d\u73fe\u53ef\u80fd\u306a\u610f\u601d\u6c7a\u5b9a\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3068\u3057\u3066\u6574\u7406\u3057\u307e\u3059\u3002\u5206\u985e\u5224\u65ad\u304b\u3089\u59cb\u307e\u308a\u3001Predicate\u9078\u5b9a\u306b\u5185\u5728\u3059\u308b\u30ea\u30b9\u30af\u3001\u8aa4\u9078\u5b9a\u6642\u306e\u5f71\u97ff\u3001\u3055\u3089\u306b\u5b9f\u52d9\u4e0a\u306e\u30ea\u30ab\u30d0\u30ea\u30fc\u6226\u7565\u307e\u3067\u3092\u4f53\u7cfb\u7684\u306b\u89e3\u8aac\u3057\u3001\u6700\u5f8c\u306b\u305d\u306e\u307e\u307e\u6d3b\u7528\u3067\u304d\u308bPredicate\u9078\u5b9a\u30e1\u30e2\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u63d0\u793a\u3057\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

    \n
  1. \u307e\u305a\u524d\u63d0\u3068\u3057\u3066\u3001510(k)\u3068De Novo\u306e\u672c\u8cea\u7684\u306a\u9055\u3044\u3092\u6574\u7406\u3057\u307e\u3059\u3002<\/span>\n

    510(k)\u306f\u3001\u65e2\u306b\u5408\u6cd5\u7684\u306b\u4e0a\u5e02\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\uff08Predicate\u00a0device\uff09\u3068\u306e\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b\u5236\u5ea6\u3067\u3059\u3002\u9069\u5fdc\u7528\u9014<\/span>\uff08<\/span>Intended\u00a0Use<\/span>\uff09\u304c\u4e00\u81f4\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u6280\u8853\u7684\u7279\u6027\u304c\u540c\u7b49\u307e\u305f\u306f\u6bd4\u8f03\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u5b89\u5168\u6027\u304a\u3088\u3073\u6709\u52b9\u6027\u304c\u540c\u7b49\u4ee5\u4e0a\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u3067\u3001\u5e02\u5834\u6295\u5165\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n

    \u3053\u306e\u30eb\u30fc\u30c8\u306e\u6700\u5927\u306e\u7279\u5fb4\u306f\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306e\u4e88\u898b\u6027\u304c\u6bd4\u8f03\u7684\u9ad8\u3044\u70b9\u306b\u3042\u308a\u307e\u3059\u3002\u516c\u5f0f\u306a\u5be9\u67fb\u76ee\u6a19\u306f90\u65e5\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5b9f\u52d9\u4e0a\u306f\u8ffd\u52a0\u8cc7\u6599\u8981\u6c42\u3078\u306e\u5bfe\u5fdc\u306a\u3069\u306b\u3088\u308a\u3001\u6982\u306d4\u301c6\u304b\u6708\u7a0b\u5ea6\u3067\u306e\u7740\u5730\u304c\u4e00\u822c\u7684\u3067\u3059\u3002AI\/ML\u3092\u7528\u3044\u305f<\/span>SaMD<\/span>\u306b\u304a\u3044\u3066\u3082\u3001\u73fe\u6642\u70b9\u3067\u306f\u5927\u534a\u304c510(k)\u3092\u9078\u629e\u3057\u3066\u3044\u308b\u306e\u304c\u5b9f\u614b\u3067\u3059\u3002<\/span><\/p>\n

    De\u00a0Novo\u306f\u3001\u9069\u5207\u306aPredicate\u304c\u5b58\u5728\u3057\u306a\u3044\u5834\u5408\u306b\u7528\u3044\u3089\u308c\u308b\u30eb\u30fc\u30c8\u3067\u3042<\/span>\u308a\u3001\u5bfe\u8c61\u306f\u4f4e\u301c\u4e2d\u30ea\u30b9\u30af\uff08Class I\u307e\u305f\u306fClass II\uff09\u306e\u88fd\u54c1\u306b\u9650\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u65b0\u305f\u306a\u88fd\u54c1\u5206\u985e\u3068\u30d7\u30ed\u30c0\u30af\u30c8\u30b3\u30fc\u30c9\u3092\u8a2d\u5b9a\u3057\u3001\u3055\u3089\u306bFDA\u304c\u53d7\u3051\u5165\u308c\u53ef\u80fd\u306a\u7279\u5225\u7ba1\u7406\u8981\u4ef6\u3092\u63d0\u6848\u3057\u306a\u304c\u3089\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u81ea\u3089\u7acb\u8a3c\u3057\u3066\u3044\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span>
    \n\u305d\u306e\u305f\u3081\u3001\u6c42\u3081\u3089\u308c\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u6c34\u6e96\u306f\u9ad8\u304f\u3001\u5be9\u67fb\u671f\u9593\u3082\u9577\u671f\u5316\u3057\u3084\u3059\u3044\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

    \u516c\u5f0f\u306b\u306f150\u301c180\u65e5\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5b9f\u52d9\u4e0a\u306f7\u301c9\u304b\u6708\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f1\u5e74\u7a0b\u5ea6\u306b\u53ca\u3076\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u672c\u8cea\u7684\u306b\u306f\u3001\u65e2\u5b58\u306e\u57fa\u6e96\u306b\u4f9d\u62e0\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u81ea\u3089\u304c\u57fa\u6e96\u3068\u306a\u3063\u3066\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308a\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3084\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u3001\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u5206\u6790\u3001\u3055\u3089\u306b\u306f\u5909\u66f4\u7ba1\u7406\u8a08\u753b\u306a\u3069\u3001\u5305\u62ec\u7684\u306a\u30a8\u30d3\u30c7\u30f3\u30b9\u3068\u7d71\u5236\u306e\u8a2d\u8a08\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

    \u00a0<\/span><\/p>\n

      \n
    1. \u3069\u306e\u30eb\u30fc\u30c8\u3092\u9078\u629e\u3059\u3079\u304d\u304b\u306b\u3064\u3044\u3066\u306f\u3001\u4e09\u3064\u306e\u5224\u65ad\u8ef8\u306b\u6574\u7406\u3059\u308b\u3053\u3068\u3067\u5927\u304d\u304f\u5916\u3059\u30ea\u30b9\u30af\u3092\u4e0b\u3052\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span>\n

      \u5224\u65ad\u30dd\u30a4\u30f3\u30c8\uff11\uff1a\u9069\u5fdc\u7528\u9014\u304c\u65e2\u627f\u8a8d\u88fd\u54c1\u3068\u6587\u8a00\u30ec\u30d9\u30eb\u3067\u4e00\u81f4\u3057\u3066\u3044\u308b\u306e\u304b\u3002<\/span>
      \n510(k)\u306b\u304a\u3044\u3066\u6700\u3082\u91cd\u8981\u306a\u306e\u306f\u6027\u80fd\u306e\u512a\u52a3\u3067\u306f\u306a\u304f\u3001\u3053\u306e\u9069\u5fdc\u7528\u9014\u306e\u4e00\u81f4\u3067\u3059\u3002\u4e00\u898b\u4f3c\u3066\u3044\u308b\u3088\u3046\u306b\u898b\u3048\u3066\u3082\u3001\u5b9a\u7fa9\u304c\u308f\u305a\u304b\u306b\u7570\u306a\u308b\u3060\u3051\u3067\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u306e\u524d\u63d0\u304c\u6210\u7acb\u3057\u306a\u304f\u306a\u308a\u3001\u3044\u304f\u3089\u6027\u80fd\u30c7\u30fc\u30bf\u3092\u7a4d\u307f\u4e0a\u3052\u3066\u3082510(k)\u3068\u3057\u3066\u6210\u7acb\u3057\u306a\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

      \u5224\u65ad\u30dd\u30a4\u30f3\u30c8\uff12\uff1a\u9632\u5fa1\u53ef\u80fd\u306aPredicate\u306f\u5b58\u5728\u3059\u308b\u306e\u304b\u3002<\/span>
      \n\u3053\u3053\u3067\u3044\u3046\u9632\u5fa1\u53ef\u80fd\u3068\u306f\u3001\u5358\u306bK\u756a\u53f7\u304c\u5b58\u5728\u3059\u308b\u3053\u3068\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u4e0a\u8ad6\u7406\u7684\u306b\u6210\u7acb\u3055\u305b\u3089\u308c\u308b\u304b\u3069\u3046\u304b\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u9069\u5fdc\u7528\u9014\u306e\u6574\u5408\u6027\u306b\u52a0\u3048\u3001\u6280\u8853\u7684\u7279\u6027\u306e\u6bd4\u8f03\u53ef\u80fd\u6027\u3001\u516c\u958b\u60c5\u5831\u306b\u57fa\u3065\u304f\u6027\u80fd\u306e\u57fa\u6e96\u8a2d\u5b9a\u3001\u65e2\u77e5\u306e\u5b89\u5168\u6027\u30ea\u30b9\u30af\u306e\u6709\u7121\u306a\u3069\u3001\u8907\u6570\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3057\u3066\u521d\u3081\u3066\u5b9f\u52d9\u4e0a\u6709\u52b9\u306aPredicate\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n

      \u5224\u65ad\u30dd\u30a4\u30f3\u30c8\uff13\uff1a\u6280\u8853\u7684\u5dee\u7570\u304c\u65b0\u305f\u306a\u5b89\u5168\u6027\u307e\u305f\u306f\u6709\u52b9\u6027\u4e0a\u306e\u554f\u984c\u3092\u751f\u3058\u3055\u305b\u306a\u3044\u304b\u3002<\/span>
      \n\u5dee\u7570\u305d\u306e\u3082\u306e\u304c\u554f\u984c\u3067\u306f\u306a\u304f\u3001\u305d\u308c\u306b\u3088\u3063\u3066\u65b0\u305f\u306a\u30ea\u30b9\u30af\u304c\u751f\u3058\u308b\u304b\u304c\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u4f8b\u3048\u3070\u51fa\u529b\u5f62\u5f0f\u306e\u9055\u3044\u3001\u4f7f\u7528\u74b0\u5883\u306e\u9055\u3044\u3001\u8a55\u4fa1\u6307\u6a19\u306e\u975e\u4e92\u63db\u6027\u306a\u3069\u306b\u3088\u308a\u65b0\u305f\u306a\u61f8\u5ff5\u304c\u3042\u308b\u3068\u5224\u65ad\u3055\u308c\u308b\u3068\u3001\u8ffd\u52a0\u8cc7\u6599\u8981\u6c42\u3084\u975e\u5b9f\u8cea\u7684\u540c\u7b49\u3068\u3044\u3063\u305f\u5224\u65ad\u306b\u3064\u306a\u304c\u308a\u3001\u7d50\u679c\u3068\u3057\u3066\u30eb\u30fc\u30c8\u5909\u66f4\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

      \u00a0<\/span><\/p>\n

        \n
      1. Predicate\u306e\u9078\u5b9a\u306b\u3064\u3044\u3066\u306f\u3001\u5019\u88dc\u306e\u62bd\u51fa\u3068\u7d5e\u308a\u8fbc\u307f\u306e\u4e8c\u6bb5\u968e\u3067\u8003\u3048\u308b\u3068\u6574\u7406\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/span>\n

        Step1:\u00a0<\/span>\u5019\u88dc\u306e\u62bd\u51fa<\/span>
        \nFDA\u306e510(k)\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3084\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3001AI\/ML\u95a2\u9023\u306e\u516c\u958b\u30ea\u30b9\u30c8\u306a\u3069\u3092\u6d3b\u7528\u3057\u3001\u30d7\u30ed\u30c0\u30af\u30c8\u30b3\u30fc\u30c9\u3068\u30ad\u30fc\u30ef\u30fc\u30c9\u3092\u7d44\u307f\u5408\u308f\u305b\u3066\u63a2\u7d22\u7bc4\u56f2\u3092\u7d5e\u308a\u8fbc\u307f\u307e\u3059\u3002<\/span>
        \n\u5b9f\u52d9\u4e0a\u306f\u3001\u76f4\u8fd12\u301c3\u5e74\u4ee5\u5185\u306b\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u3092\u512a\u5148\u7684\u306b\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3001\u73fe\u884c\u306e\u5be9\u67fb\u57fa\u6e96\u3068\u306e\u4e56\u96e2\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/span><\/p>\n

        Step2 :\u00a0<\/span>\u5019\u88dc\u306e\u7d5e\u308a\u8fbc\u307f<\/span>
        \n\u76f4\u8fd1<\/span>2\u5e74\u4ee5\u5185\u306b<\/span>\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u3067\u3042\u308b\u3053\u3068\u3001\u65e2\u77e5\u306e\u5b89\u5168\u6027\u554f\u984c\u304c\u306a\u3044\u3053\u3068\u3001\u6027\u80fd\u304c\u4e00\u5b9a\u7a0b\u5ea6\u5b9f\u8a3c\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3001\u91cd\u5927\u306a\u8a2d\u8a08\u4e0a\u306e\u554f\u984c\u304c\u306a\u3044\u3053\u3068\u3001\u3068\u3044\u3063\u305f\u70b9\u304c\u91cd\u8981\u306a\u5224\u65ad\u57fa\u6e96\u3068\u306a\u308a\u307e\u3059\u3002<\/span>
        \n\u306a\u304a\u3001Predicate\u306f\u5fc5\u305a\u3057\u3082AI\u3067\u3042\u308b\u5fc5\u8981\u306f\u306a\u304f\u3001\u81e8\u5e8a\u7684\u306a\u540c\u7b49\u6027\u304c\u8aac\u660e\u53ef\u80fd\u3067\u3042\u308c\u3070\u5f93\u6765\u578b\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3082\u9078\u629e\u80a2\u3068\u306a\u308a\u307e\u3059\u3002\u4e00\u65b9\u3067\u3001\u8907\u6570\u306ePredicate\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u624b\u6cd5\u306f\u8ad6\u7406\u304c\u4e0d\u5b89\u5b9a\u306b\u306a\u308a\u3084\u3059\u304f\u3001\u5b9f\u52d9\u4e0a\u306f\u5358\u4e00\u306ePredicate\u306b\u57fa\u3065\u304f\u69cb\u6210\u304c\u671b\u307e\u308c\u307e\u3059\u3002<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

        \u00a0<\/span><\/p>\n

          \n
        1. Predicate\u9078\u5b9a\u3092\u8aa4\u3063\u305f\u5834\u5408\u306e\u5f71\u97ff\u306f\u5927\u304d\u304f\u3001\u5358\u306a\u308b\u5dee\u3057\u623b\u3057\u306b\u3068\u3069\u307e\u308a\u307e\u305b\u3093\u3002<\/span>
          \nAI\u00a0SaMD<\/span>\u9818\u57df\u3067\u306fPredicate\u306b\u95a2\u3059\u308b\u8ad6\u70b9\u304c\u983b\u7e41\u306b\u767a\u751f\u3057\u3066\u304a\u308a\u3001\u975e\u5b9f\u8cea\u7684\u540c\u7b49\u3068\u5224\u65ad\u3055\u308c\u308b\u5272\u5408\u3082\u7121\u8996\u3067\u304d\u306a\u3044\u6c34\u6e96\u306b\u3042\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

          \u00a0<\/span><\/p>\n

          \u307e\u305a\u5be9\u67fb\u306e\u9045\u5ef6\u304c\u767a\u751f\u3057\u3001\u8ffd\u52a0\u8cc7\u6599\u5bfe\u5fdc\u306e\u5f80\u5fa9\u306b\u3088\u308a\u6570\u304b\u6708\u5358\u4f4d\u3067\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u5f8c\u308d\u5012\u3057\u306b\u306a\u308a\u307e\u3059\u3002\u6b21\u306b\u3001\u8ffd\u52a0\u8a66\u9a13\u3084\u30c7\u30fc\u30bf\u88dc\u5b8c\u306b\u3088\u308b\u30b3\u30b9\u30c8\u5897\u52a0\u304c\u767a\u751f\u3057\u3001\u6570\u4e07\u30c9\u30eb\u898f\u6a21\u306e\u8ffd\u52a0\u8ca0\u62c5\u3068\u306a\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u305d\u3057\u3066\u6700\u3082\u5f71\u97ff\u304c\u5927\u304d\u3044\u306e\u304c\u3001\u30eb\u30fc\u30c8\u5909\u66f4\u3067\u3059\u3002\u518d\u63d0\u51fa\u3084De Novo\u3078\u306e\u79fb\u884c\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001\u305d\u308c\u307e\u3067\u306e\u6295\u8cc7\u304c\u5b9f\u8cea\u7684\u306b\u7121\u52b9\u5316\u3055\u308c\u308b\u30b1\u30fc\u30b9\u3082\u3042\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

          \u00a0<\/span><\/p>\n

            \n
          1. 3<\/span>\u6bb5\u968e\u306e\u30ea\u30ab\u30d0\u30ea\u30fc\u6226\u7565<\/span>
            \n\u672c\u5bfe\u5fdc\u306e\u76ee\u7684\u306f\u3001\u72b6\u6cc1\u306e\u60aa\u5316\u3092\u6291\u3048\u3064\u3064\u3001\u5b9f\u8cea\u7684\u540c\u7b49\u6027\uff08Substantial Equivalence\uff09\u306e\u8ad6\u8a3c\u3092\u5b89\u5b9a\u7684\u306b\u7acb\u3066\u76f4\u3059\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

            \u307e\u305a\u7b2c\u4e00\u306b\u3001\u4ee3\u66ff\u3068\u306a\u308bPredicate\u306e\u6d3b\u7528\u3067\u3059\u3002\u3042\u3089\u304b\u3058\u3081\u7b2c\u4e8c\u5019\u88dc\u3092\u6e96\u5099\u3057\u3066\u3044\u308b\u5834\u5408\u306b\u306f\u3001\u3053\u306e\u6bb5\u968e\u3067\u901f\u3084\u304b\u306b\u5207\u308a\u66ff\u3048\u308b\u3053\u3068\u3067\u3001\u4e0d\u9069\u5207\u306aPredicate\u306b\u5bfe\u3057\u3066\u8ffd\u52a0\u8cc7\u6599\u306e\u63d0\u51fa\u3092\u91cd\u306d\u308b\u30ea\u30b9\u30af\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002<\/span><\/p>\n

            \u7b2c\u4e8c\u306b\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u968e\u5c64\u69cb\u9020\u3092\u610f\u8b58\u3057\u305f\u88dc\u5f37\u3092\u884c\u3044\u307e\u3059\u3002FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u95a2\u9023\u3059\u308b\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u898f\u683c\u3001\u67fb\u8aad\u4ed8\u304d\u6587\u732e\u306a\u3069\u3092\u57fa\u306b\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u3092\u6574\u7406\u3057\u305f\u4e0a\u3067\u3001\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u3068\u306e\u6bd4\u8f03\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u540c\u7b49\u6027\u306e\u4e3b\u5f35\u3092\u5b9a\u91cf\u7684\u306b\u88cf\u4ed8\u3051\u3066\u3044\u304d\u307e\u3059\u3002<\/span><\/p>\n

            \u7b2c\u4e09\u306b\u3001\u6280\u8853\u7684\u5dee\u7570\u306e\u6574\u7406\u3067\u3059\u3002\u5dee\u7570\u3092\u5358\u306b\u5217\u6319\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u691c\u8a3c\u53ef\u80fd\u306a\u30af\u30ec\u30fc\u30e0\u3068\u3057\u3066\u518d\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3001\u5be9\u67fb\u306e\u8ad6\u70b9\u3092\u81ea\u793e\u304c\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u53ef\u80fd\u306a\u8a55\u4fa1\u9805\u76ee\uff08\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\uff09\u3078\u3068\u9069\u5207\u306b\u5f15\u304d\u623b\u3059\u3053\u3068\u304c\u91cd\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

            \u00a0<\/span><\/p>\n

              \n
            1. De Novo\u306f\u300c\u3088\u308a\u96e3\u3057\u3044510(k<\/span>)\u300d\u3067\u306f\u306a\u304f\u3001\u7570\u306a\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u6226\u7565\u3067\u3042\u308b<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

              Predicate\u304c\u5b58\u5728\u3057\u306a\u3044\u5834\u5408\u306b\u306f\u3001\u3088\u308a\u5305\u62ec\u7684\u306a\u30c7\u30fc\u30bf\u3068\u7ba1\u7406\u63aa\u7f6e\u306b\u57fa\u3065\u304d\u3001\u5b89\u5168\u6027\u304a\u3088\u3073\u6709\u52b9\u6027\u3092\u72ec\u7acb\u3057\u3066\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u305d\u306e\u3046\u3048\u3067\u7279\u5225\u7ba1\u7406\u8981\u4ef6\uff08Special\u00a0Controls\uff09\u3092\u81ea\u3089\u63d0\u6848\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

              De Novo\u306b\u304a\u3051\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u30d1\u30c3\u30b1\u30fc\u30b8\u306f\u3001\u4e00\u822c\u7684\u306b\u3088\u308a\u5145\u5b9f\u3057\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3001\u3042\u308b\u3044\u306f\u591a\u65bd\u8a2d\u304b\u3089\u5f97\u3089\u308c\u308b\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\uff08RWE\uff09\u3001\u3055\u3089\u306b\u72ec\u7acb\u6027\u3068\u5b9a\u91cf\u6027\u3092\u5099\u3048\u305f\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u5206\u6790\uff08risk-benefit\uff09\u306a\u3069\u3067\u69cb\u6210\u3055\u308c\u307e\u3059\u3002\u52a0\u3048\u3066\u3001\u88fd\u54c1\u7279\u6027\u306b\u5fdc\u3058\u305f\u7279\u5225\u7ba1\u7406\u8981\u4ef6\u306e\u8a2d\u8a08\u30fb\u63d0\u793a\u3082\u91cd\u8981\u306a\u8981\u7d20\u3068\u306a\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

              \u7279\u306bAI\/ML\u3092\u7528\u3044\u305f\u88fd\u54c1\u306b\u304a\u3044\u3066\u306f\u3001PCCP\uff08Predetermined Change Control Plan\uff09\u304c\u91cd\u8981\u306a\u4f4d\u7f6e\u3065\u3051\u3092\u6301\u3061\u307e\u3059\u3002\u3053\u308c\u306f\u5c06\u6765\u7684\u306a\u30e2\u30c7\u30eb\u5909\u66f4\u304c\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u308b\u3053\u3068\u3092\u793a\u3059\u305f\u3081\u306e\u67a0\u7d44\u307f\u3067\u3042\u308a\u3001\u88fd\u54c1\u306e\u7d99\u7d9a\u7684\u306a\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u304c\u898f\u5236\u4e0a\u306e\u4e0d\u78ba\u5b9f\u6027\u3001\u3044\u308f\u3086\u308b\u300c\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u5316\u300d\u3092\u62db\u304b\u306a\u3044\u3088\u3046\u62c5\u4fdd\u3059\u308b\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

              \u00a0<\/span><\/p>\n

                \n
              1. \u305d\u306e\u307e\u307e\u6d3b\u7528\u3067\u304d\u308bPredicate\u9078\u5b9a\u30e1\u30e2\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/span>\u00a0<\/span><\/li>\n<\/ol>\n

                \u4ee5\u4e0b\u306e\u30e1\u30e2\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u30c1\u30fc\u30e0\u5185\u3067\u5171\u6709\u3059\u308b\u3053\u3068\u3067\u3001\u53e3\u982d\u3067\u306e\u8b70\u8ad6\u306b\u6bd4\u3079\u3066\u8fc5\u901f\u306b\u8a8d\u8b58\u3092\u63c3\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u3055\u3089\u306bQ-Submission\u3084510(k)\u7533\u8acb\u66f8\u985e\u3078\u306e\u8ee2\u7528\u3082\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/span>
                \n\u00a0<\/span><\/p>\n

                \u7b2c\u4e00\u306b\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u6982\u8981\u3092\u6574\u7406\u3057\u307e\u3059\u3002<\/span>
                \n\u3053\u3053\u3067\u306f\u3001\u88fd\u54c1\u540d\u3001\u9069\u5fdc\u7528\u9014\uff08Intended Use\u307e\u305f\u306fIndication\uff09\u306e\u30c9\u30e9\u30d5\u30c8\u3001\u81e8\u5e8a\u73fe\u5834\u306b\u304a\u3051\u308b\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u4e09\u70b9\u3092\u7c21\u6f54\u306b\u8a18\u8f09\u3057\u307e\u3059\u3002\u7279\u306b\u3001\u5165\u529b\u30c7\u30fc\u30bf\u3001\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u51fa\u529b\u3001\u533b\u5e2b\u306e\u610f\u601d\u6c7a\u5b9a\u304c\u4ecb\u5728\u3059\u308b\u30dd\u30a4\u30f3\u30c8\u306e\u95a2\u4fc2\u6027\u3092\u660e\u78ba\u306b\u793a\u3059\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u7b2c\u4e8c\u3001\u5019\u88dc\u3068\u306a\u308bPredicate\u306e\u4e00\u89a7\u3092\u6574\u7406\u3057\u307e\u3059\u3002\u5c11\u306a\u304f\u3068\u3082\u4e09\u3064\u306e\u5019\u88dc\u3092\u6319\u3052\u3001\u305d\u308c\u305e\u308c\u306b\u3064\u3044\u3066\u8a55\u4fa1\u3092\u884c\u3044\u307e\u3059\u3002\u307e\u305a\u306f\u9069\u5fdc\u7528\u9014\u306e\u6574\u5408\u6027\u3092\u78ba\u8a8d\u3057\u3001\u6587\u8a00\u30ec\u30d9\u30eb\u3067\u306e\u4e00\u81f4\u304c\u53ef\u80fd\u304b\u3001\u5bfe\u8c61\u3068\u306a\u308b\u89e3\u5256\u90e8\u4f4d\u3084\u60a3\u8005\u96c6\u56e3\u3001\u60f3\u5b9a\u30e6\u30fc\u30b6\u30fc\u304c\u4e00\u81f4\u3057\u3066\u3044\u308b\u304b\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002\u305d\u306e\u3046\u3048\u3067\u6280\u8853\u7684\u306a\u6bd4\u8f03\u53ef\u80fd\u6027\u3092\u78ba\u8a8d\u3057\u3001\u51fa\u529b\u5f62\u5f0f\u304c\u4e00\u81f4\u3057\u3066\u3044\u308b\u304b\u3001\u4f8b\u3048\u3070\u30d2\u30fc\u30c8\u30de\u30c3\u30d7\u3084\u30c8\u30ea\u30a2\u30fc\u30b8\u3068\u3044\u3063\u305f\u8868\u793a\u65b9\u6cd5\u306e\u9055\u3044\u304c\u554f\u984c\u306b\u306a\u3089\u306a\u3044\u304b\u3092\u691c\u8a0e\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u611f\u5ea6\u3001\u7279\u7570\u5ea6\u3001AUC\u306a\u3069\u306e\u6027\u80fd\u6307\u6a19\u304c\u6bd4\u8f03\u53ef\u80fd\u3067\u3042\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u5b9f\u52d9\u4e0a\u91cd\u8981\u3068\u306a\u308b\u89b3\u70b9\u3068\u3057\u3066\u3001\u76f4\u8fd1\u6570\u5e74\u4ee5\u5185\u306e\u627f\u8a8d\u3067\u3042\u308b\u304b\u3001\u6709\u5bb3\u4e8b\u8c61\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u304a\u3044\u3066\u91cd\u5927\u306a\u554f\u984c\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u306a\u3044\u304b\u3001\u6027\u80fd\u3092\u88cf\u4ed8\u3051\u308b\u516c\u958b\u60c5\u5831\u304c\u5b58\u5728\u3059\u308b\u304b\u3001\u8a2d\u8a08\u4e0a\u306e\u91cd\u5927\u306a\u61f8\u5ff5\u304c\u306a\u3044\u304b\u3068\u3044\u3063\u305f\u70b9\u3092\u7dcf\u5408\u7684\u306b\u8a55\u4fa1\u3057\u307e\u3059\u3002\u52a0\u3048\u3066\u3001\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u6ce8\u8a18\u3082\u660e\u78ba\u306b\u8a18\u8f09\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u8ad6\u8a3c\u306e\u6210\u7acb\u306b\u8907\u6570\u306ePredicate\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408\u306f\u9ad8\u30ea\u30b9\u30af\u3068\u5224\u65ad\u3057\u3001\u307e\u305fAI\u3067\u306f\u306a\u3044Predicate\u3092\u63a1\u7528\u3059\u308b\u5834\u5408\u306b\u306f\u3001\u3069\u306e\u3088\u3046\u306b\u540c\u7b49\u6027\u3092\u8aac\u660e\u3059\u308b\u304b\u3001\u305d\u306e\u305f\u3081\u306e\u6bd4\u8f03\u8a66\u9a13\u306e\u8a2d\u8a08\u65b9\u91dd\u307e\u3067\u5177\u4f53\u7684\u306b\u6574\u7406\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u7b2c\u4e09\u3068\u3057\u3066\u3001\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u6226\u7565\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002\u4e3b\u305f\u308bPredicate\u3068\u4ee3\u66ff\u3068\u306a\u308bPredicate\u3092\u5b9a\u7fa9\u3057\u305f\u3046\u3048\u3067\u3001\u4e21\u8005\u3068\u306e\u9593\u306b\u5b58\u5728\u3059\u308b\u5dee\u7570\u3092\u4e00\u89a7\u5316\u3057\u3001\u305d\u308c\u305e\u308c\u306b\u5bfe\u5fdc\u3059\u308b\u691c\u8a3c\u8a08\u753b\u3092\u6574\u7406\u3057\u307e\u3059\u3002\u3042\u308f\u305b\u3066\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u968e\u5c64\u3092\u8e0f\u307e\u3048\u305f\u88dc\u5f37\u8a08\u753b\u3092\u793a\u3057\u3001\u516c\u958b\u60c5\u5831\u304c\u4e0d\u8db3\u3059\u308b\u5834\u5408\u306b\u3069\u306e\u6587\u732e\u3084\u898f\u683c\u3001\u65e2\u5b58\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u57fa\u6e96\u3092\u69cb\u7bc9\u3059\u308b\u306e\u304b\u3092\u5177\u4f53\u7684\u306b\u8a18\u8f09\u3057\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u7b2c\u56db\u3068\u3057\u3066\u3001Q-Submission\u306e\u8a08\u753b\u3092\u7b56\u5b9a\u3057\u307e\u3059\u3002\u63d0\u51fa\u6642\u671f\u306f\u901a\u5e38\u3001\u6b63\u5f0f\u7533\u8acb\u306e1\u301c2\u304b\u6708\u524d\u3092\u76ee\u5b89\u3068\u3057\u3001\u305d\u306e\u3046\u3048\u3067FDA\u304b\u3089\u5f97\u305f\u3044\u7d50\u8ad6\u3092\u660e\u78ba\u306b\u8a00\u8a9e\u5316\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u9078\u5b9a\u3057\u305fPredicate\u306e\u59a5\u5f53\u6027\u3001\u5206\u985e\u306e\u9069\u5207\u6027\u3001\u8a66\u9a13\u8a08\u753b\u306e\u53d7\u5bb9\u6027\u3068\u3044\u3063\u305f\u8ad6\u70b9\u306b\u3064\u3044\u3066\u3001\u3069\u306e\u3088\u3046\u306a\u56de\u7b54\u3092\u671f\u5f85\u3059\u308b\u306e\u304b\u3092\u4e8b\u524d\u306b\u6574\u7406\u3057\u3066\u304a\u304d\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u6700\u5f8c\u306b\u3001\u5fc5\u8981\u3068\u306a\u308b\u30ea\u30bd\u30fc\u30b9\u304a\u3088\u3073\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u4e0a\u306e\u30ea\u30b9\u30af\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002\u8ffd\u52a0\u8a66\u9a13\u3001\u30c7\u30fc\u30bf\u53d6\u5f97\u3001\u5916\u90e8\u306e\u81e8\u5e8a\u652f\u63f4\u3084\u7d71\u8a08\u89e3\u6790\u652f\u63f4\u306a\u3069\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u3092\u898b\u7a4d\u3082\u308b\u3068\u3068\u3082\u306b\u3001\u6700\u60aa\u306e\u30b7\u30ca\u30ea\u30aa\u306b\u3064\u3044\u3066\u3082\u5177\u4f53\u7684\u306b\u60f3\u5b9a\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u975e\u5b9f\u8cea\u7684\u540c\u7b49\uff08NSE\uff09\u3068\u5224\u65ad\u3055\u308cDe Novo\u3078\u79fb\u884c\u3059\u308b\u5834\u5408\u306b\u306f\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u671f\u9593\u304c6\u301c9\u304b\u6708\u5ef6\u9577\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u305d\u308c\u304c\u8cc7\u91d1\u6d88\u8cbb\u3084\u8cc7\u91d1\u8abf\u9054\u8a08\u753b\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u304b\u307e\u3067\u8e0f\u307f\u8fbc\u3093\u3067\u8a55\u4fa1\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u00a0<\/span><\/p>\n

                \u7d50\u8ad6\uff08\u6295\u8cc7\u5bb6\u306e\u8996\u70b9\uff09<\/span>
                \n\u6295\u8cc7\u304a\u3088\u3073\u4e8b\u696d\u904b\u55b6\u306e\u89b3\u70b9\u304b\u3089\u898b\u308b\u3068\u3001510(k)\u3068De Novo\u306e\u9078\u629e\u306f\u3001\u672c\u8cea\u7684\u306b\u306f\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u8a2d\u8a08\u3068\u30ad\u30e3\u30c3\u30b7\u30e5\u30d5\u30ed\u30fc\u7ba1\u7406\u306e\u554f\u984c\u3067\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

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                \u4e00\u65b9\u3067\u3001De Novo\u306e\u4fa1\u5024\u306f\u300c\u3088\u308a\u96e3\u3057\u3044\u300d\u3042\u308b\u3044\u306f\u300c\u5148\u9032\u7684\u3067\u3042\u308b\u300d\u3068\u3044\u3046\u70b9\u306b\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3080\u3057\u308d\u3001\u81ea\u3089\u30d7\u30ed\u30c0\u30af\u30c8\u30b3\u30fc\u30c9\u304a\u3088\u3073\u7279\u5225\u7ba1\u7406\u8981\u4ef6\uff08Special Controls\uff09\u3092\u5b9a\u7fa9\u3057\u3001\u5f53\u8a72\u9818\u57df\u306b\u304a\u3051\u308b\u30eb\u30fc\u30eb\u30e1\u30a4\u30ad\u30f3\u30b0\u306b\u95a2\u4e0e\u3067\u304d\u308b\u70b9\u306b\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u305d\u306e\u5bfe\u4fa1\u3068\u3057\u3066\u6c42\u3081\u3089\u308c\u308b\u306e\u306f\u3001\u3088\u308a\u9ad8\u5bc6\u5ea6\u306a\u30a8\u30d3\u30c7\u30f3\u30b9\u3068\u3001\u53b3\u683c\u306a\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u4f53\u5236\u3067\u3059\u3002\u7279\u306bAI\/ML\u88fd\u54c1\u306b\u304a\u3044\u3066\u306f\u3001PCCP\u304a\u3088\u3073\u7d99\u7d9a\u7684\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u4f53\u5236\u304c\u3001\u5b9f\u88c5\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u306b\u52a0\u3048\u3001\u76e3\u67fb\u53ef\u80fd\u306a\u5f62\u3067\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3068\u306a\u308a\u307e\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u5b9f\u52d9\u7684\u306a\u89b3\u70b9\u304b\u3089\u6700\u3082\u5408\u7406\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u4e0d\u78ba\u5b9f\u6027\u3092\u3067\u304d\u308b\u9650\u308a\u524d\u5012\u3057\u3067\u89e3\u6d88\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001Q-Submission\u3092\u6d3b\u7528\u3057\u3001\u7533\u8acb\u524d\u306e\u6bb5\u968e\u3067\u5206\u985e\u304a\u3088\u3073Predicate\u306e\u65b9\u5411\u6027\u3092\u660e\u78ba\u5316\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u9650\u3089\u308c\u305f\u30ea\u30bd\u30fc\u30b9\u3092\u3001\u627f\u8a8d\u304a\u3088\u3073\u53ce\u76ca\u5316\u306b\u3064\u306a\u304c\u308b\u78ba\u5ea6\u306e\u9ad8\u3044\u30a8\u30d3\u30c7\u30f3\u30b9\u69cb\u7bc9\u306b\u96c6\u4e2d\u3055\u305b\u308b\u3053\u3068\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002\u5be9\u67fb\u306e\u9014\u4e2d\u3067\u65b9\u91dd\u8ee2\u63db\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u308b\u4e8b\u614b\u3092\u907f\u3051\u308b\u3053\u3068\u306f\u3001\u88fd\u54c1\u958b\u767a\u306e\u307f\u306a\u3089\u305a\u3001\u8cc7\u672c\u653f\u7b56\u5168\u4f53\u306e\u5b89\u5b9a\u6027\u3092\u7dad\u6301\u3059\u308b\u3046\u3048\u3067\u3082\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002<\/span>\u00a0<\/span><\/p>\n

                \u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001<\/span>Joseph.Shen@behealthventures.com\u00a0<\/span>\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/span>\u00a0<\/span><\/p>\n

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