摘要
目的从技术审评的角度明确CT肺结节测评数据库的构建要求。方法本文基于国内外AI医疗器械监管要求的调研,结合多项AI医疗器械的技术审评工作经验,提出CT肺结节测评数据库的构建要求。结果CT肺结节测评数据库应具备权威性、科学性、规范性、多样性、封闭性和动态性等特点,方能满足AI CT肺结节辅助检测/诊断软件的确认要求。结论本文前瞻性地提出CT肺结节测评数据库的构建要求,不仅可以指导相关责任方筹建符合技术审评要求的测评数据库,而且可以为探索CT肺结节测评数据库取代或部分取代临床评价的可行性提供参考。
Objective To clarify the technical evaluation requirements for the construction of CT reference database for pulmonary nodules from technical perspective.Methods Based on the research on relevant regulatory requirements for artificial intelligence(AI)medical devices at home and abroad,combined with the experience of technical evaluating numbers of AI medical devices,this paper put forward the requirements of CT reference database for pulmonary nodules.Results CT reference database for pulmonary nodules should be authoritative,scientific,normative,diversified,closed and dynamic,so as to meet the validation requirements of AI CT assisted software for pulmonary nodule.Conclusion This paper prospectively put forward the requirements of CT reference database for pulmonary nodules,which can not only guide the relevant responsible parties to construct the reference database meeting the technical evaluation requirements,but also provide a reference for exploring the feasibility of CT reference database for pulmonary nodules replacing or partially replacing clinical evaluation.
作者
郑晨
张宇晶
彭亮
蒋薇
鲍雅晴
ZHENG Chen;ZHANG Yujing;PENG Liang;JIANG Wei;BAO Yaqing(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China;National Health Commission Capacity Building and Continuing Education Center,Beijing 100191,China)
出处
《中国医疗设备》
2021年第12期19-21,34,共4页
China Medical Devices
基金
北京市科学技术委员会资助课题(Z201100005620002)。
关键词
人工智能医疗器械软件
测评数据库
技术审评
肺结节
artificial intelligence assisted medical software
reference database
technical evaluation
pulmonary nodules
