1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China丨
2. National Health Commission Capacity Building and Continuing Education Center, Beijing 100191, China
Abstract: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.
郑晨1,张宇晶1,彭亮1,蒋薇2,鲍雅晴1. 构建CT肺结节测评数据库的技术审评要求分析[J]. 中国医疗设备, 2021, 36(12): 19-21.
ZHENG Chen1,ZHANG Yujing1,PENG Liang1,JIANG Wei2,BAO Yaqing1. Analysis of Technical Review Evaluation Requirements for Construction of CT Reference
Database for Pulmonary Nodules. China Medical Devices, 2021, 36(12): 19-21.