人工智能医疗器械辅助诊断及探测性能评估参数的讨论

Discussion on Evaluation Parameters of Auxillary Diagnosis and Detection Performance of Artificial Intelligence Medical Devices

目的:人工智能医疗器械的应用越来越广泛,但目前并没有对其性能的评价标准。希望通过本文研究为人工智能医疗器械的客观评估提供帮助。方法:从不同的应用角度对人工智能医疗器械评估参数进行了梳理,比较了各个参数的特点和使用场景。结果与结论:不同的评估参数所适用的场景不同,评估结果也存在差异,在进行人工智能产品评价时应根据产品特性合理选择。

Objective:The application of artificial intelligence medical devices is more and more extensive,but there is no evaluation standard for their performance currently.It is hoped that this paper will provide some help for objective evaluation of artificial intelligence medical devices.Methods:The evaluation parameters of artificial intelligence medical devices were analyzed from different application perspectives,and the characteristics and application scenarios of each parameter were compared.Results and Conclusion:Different evaluation parameters can be used for different scenarios,leading to different evaluation results.Therefore,in the evaluation of artificial intelligence products,selection should be made according to the characteristics of the products.