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Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan
The development of computer-aided detection (CAD) using artificial intelligence (AI) and machine learning (ML) is rapidly evolving. Submission of AI/ML-based CAD devices for regulatory approval requires information about clinical trial design and performance criteria, but the requirements vary betwe...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Nature Publishing Group UK
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9542463/ https://www.ncbi.nlm.nih.gov/pubmed/36207474 http://dx.doi.org/10.1038/s41598-022-21426-7 |