Publication: FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks
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Muehlematter, U. J., Bluethgen, C., & Vokinger, K. N. (2023). FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks. The Lancet Digital Health, 5, e618–e626. https://doi.org/10.1016/S2589-7500(23)00126-7
Abstract
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Abstract
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equivalent to a former cleared device (ie, predicate). We analysed the predicate networks of cleared AI/ML-based medical devices (cleared between 2019 and 2021), their underlying tasks, and recalls. More than a third of cleared AI/ML-based medical devices originated from non-AI/ML-based medical devices
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- Muehlematter, Urs J
- Bluethgen, Christian
- Vokinger, Kerstin N
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Muehlematter, U. J., Bluethgen, C., & Vokinger, K. N. (2023). FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks. The Lancet Digital Health, 5, e618–e626. https://doi.org/10.1016/S2589-7500(23)00126-7
