Expert Consensus on General Methods for Performance Evaluation of Artificial Intelligence Medical Devices (2023)

Artificial intelligence medical devices are rapidly evolving, and the performance evaluation methods of the products need to be standardized and innovated. With the goal of promoting industry, supporting supervision, and improving the quality of artificial intelligence medical device products, Zhejiang University, in cooperation with a number of professional institutions such as the National Institutes for Food and Drug Control, and relying on the centralized unit of artificial intelligence medical device standardization technology, led the efforts to analyze the common problems in performance evaluation and summarize related test methods of these devices. Based on the consensus of the expert group, this paper introduces various test methods and their applications in detail, and expounds the sampling of test data. The aim is to unify understanding, promote thestandardization of artificial intelligence medical device performance evaluation methods, and finally boost the high-quality development of artificial intelligence medical devices.