FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks

نویسندگان

چکیده

The US Food and Drug Administration is clearing an increasing number of artificial intelligence machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if device substantially equivalent to a former cleared (ie, predicate). We analysed predicate networks AI/ML-based (cleared between 2019 2021), their underlying tasks, recalls. More than third originated from non-AI/ML-based in first generation. Devices with longest time since last AI/ML component were haematology (2001), radiology cardiovascular (2008). Especially for radiology, tasks changed frequently along device's network, raising safety concerns. To date, only few recalls might have affected components. improve patient care, stronger focus should be placed on distinctive characteristics when defining substantial equivalence new devices.

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ژورنال

عنوان ژورنال: The Lancet Digital Health

سال: 2023

ISSN: ['2589-7500']

DOI: https://doi.org/10.1016/s2589-7500(23)00126-7