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中国医疗器械杂志 2019, Vol. 43 Issue (5) :379-383    DOI: 10.3969/j.issn.1671-7104.2019.05.019
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美国上市影像类人工智能辅助诊断软件临床评价的研究与思考
胡凯,甄辉,杨辉,夏建松,何蕊
浙江省医疗器械审评中心,杭州市,311121
Study on the Clinical Evaluation of Image-based Artificial Intelligence Aided Diagnosis Software Approved in the United States
HU Kai, ZHEN Hui, YANG Hui, XIA Jiansong, HE Rui
Zhejiang Medical Device Evaluation Center, Hangzhou, 311121  

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摘要 人工智能,作为当前信息技术的重要突破,正在越来越多的行业中得到重视并运用于实践。将人工智能应用到医疗领域 的研究也逐渐成熟并有部分产品问世。美国已有相关产品得到FDA的审批,其主要是影像类软件产品。该文通过研究美 国FDA审批的影像类人工智能辅助诊断软件的案例,集中分析代表性的产品的上市途径、临床评价方式、临床数据处 理,归纳美国FDA对影像类人工智能辅助诊断软件的临床评价特点。最后对我国同类产品的临床评价可能遇到的问题进 行思考,并提出相关的建议。
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关键词辅助诊断软件   人工智能   临床评价   医疗器械     
Abstract: Artificial intelligence, as the breakthrough of current information technology, is gaining importance and being applied in more and more industries. Research on the application of artificial intelligence to the medical field has gradually matured and some products have come out. Relevant products in the United States have been approved by the FDA, mainly for image-based software products. In this paper, we studied the cases of image-based artificial intelligence aided diagnosis software approved by the US FDA, and analyzed the listing routes, clinical evaluation methods and clinical data processing of representative artificial intelligence products, and summarized the clinical evaluation characteristics of FDA for image-based artificial intelligence aided diagnosis software. Finally, problems that may be encountered in the clinical evaluation of similar products in China were considered, and relevant suggestions were put forward.
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Received 2019-03-20;
Corresponding Authors: 杨辉     Email: 15397081802@163.com
About author: 胡凯,E-mail: hukai666@126.com
引用本文:   
胡凯,甄辉,杨辉,夏建松,何蕊.美国上市影像类人工智能辅助诊断软件临床评价的研究与思考[J]  中国医疗器械杂志, 2019,V43(5): 379-383
HU Kai, ZHEN Hui, YANG Hui, XIA Jiansong, HE Rui.Study on the Clinical Evaluation of Image-based Artificial Intelligence Aided Diagnosis Software Approved in the United States[J]  Chinese Journal of Medical Instrumentation, 2019,V43(5): 379-383
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