Standards Development
This document specifies algorithm performance test methods of computer assisted analysis software for pulmonary images based on artificial intelligence technology. This document is applicable to medical device that uses artificial intelligence to achieve post-processing functions such as computer assisted diagnosis, detection, screening, triage, priority evaluation and prognosis assessment
AI-supported analysis of radiology images is a brooming subbranch of medical device industry and numerous products have been approved on markets worldwide. Currently there is no specific international standard regarding testing of such products. In this proposal, specific methods and metrics are described to support verification of algorithm performance. This proposal also covers general verification requirement in Annex A, which may be covered over time by more general AI-enabled medical device standards (e.g. IEC 63450 or NP based on PT8)
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