Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan
Abstract 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 v...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2022-10-01
|
| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-21426-7 |