Black Box AI

Black Box in medical imaging AI refers to an AI system in which the user can see the input and the output, but the process by which the system makes a prediction or decision is not clear to the user. According to the U.S. Food & Drug Administration, in some instances, the rules used by AI algorithms may not be possible to explain. In these instances, the International Medical Device Regulators Forum Risk Categorization System can help to calibrate evidence needed to assure algorithm efficacy and safety (U.S. FDA).

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