Research on Safety and Effectiveness Evaluation Method of Auxiliary
Diagnostic Software for Diabetic Retinopathy
LIU Xiaoyin1，LIANG Hong1，GUO Zhaojun1，HE Weigang2
1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China丨 2. Yangtze River Delta
Region Center for Medical Device Evaluation and Inspection, National Medical Products Administration, Shanghai 201203, China
Abstract：Diabetic retinopathy is a progressive blinding eye disease. In recent years, artificial intelligence diabetic retinopathy
diagnostic software has been developed. However, there is no corresponding security effectiveness evaluation method, based on the
existing regulatory framework of deep learning algorithm, this paper proposed evaluation method for the safety and effectiveness of the
algorithm performance and generalization ability, including quality control on training data, human-computer cooperation, algorithm
performance evaluation, performance influencing factor evaluation, notes for attention, and cyber security, warning and attention.
The evaluation method can effectively guide the registration work of related products and provide reference for similar products.
刘枭寅1，梁宏1，郭兆君1，贺伟罡2. 糖尿病视网膜病变辅助诊断软件安全有效性评价方法研究[J]. 中国医疗设备, 2021, 36(12): 22-24.
LIU Xiaoyin1，LIANG Hong1，GUO Zhaojun1，HE Weigang2. Research on Safety and Effectiveness Evaluation Method of Auxiliary
Diagnostic Software for Diabetic Retinopathy. China Medical Devices, 2021, 36(12): 22-24.
