AI医学影像辅助决策软件FDA临床要求浅析

Analysis of FDA's clinical requirements for AI medical image-assisted decision-making software

分析近年美国FDA批准的基于AI技术的医学影像辅助决策软件产品的审评报告,归纳和总结FDA关于此类医疗器械上市审批时对临床证据的具体要求。基于FDA网站AI医疗器械数据,汇总分析AI医学影像辅助决策软件的产品注册情况。FDA用于支持AI医学影像辅助决策软件安全有效性证据包括独立性能评估和临床性能评估,并根据产品临床风险要求提交充分的临床证据,这对我国相关医疗器械的监管具有借鉴意义。

To analyze the review reports of AI medical image-assisted decision-making software approved by FDA in recent years,and to summarize FDA's requirements for clinical evidence in the approval of such medical devices.Based on the AI medical device data from FDA website,the product registration of AI medical image-assisted decisionmaking software was summarized and analyzed.To support safety and effectiveness of AI medical image-assisted decision-making software,FDA requires evidence include standalone performance assessment and clinical performance assessment,and sufficient clinical evidence is required in accordance with clinical risks of the products,which has certain reference significance to our country's related medical device regulation.