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Standards Development
This document defines a standardized performance evaluation process for Machine Learning-enabled Medical Devices. The set of processes, activities, and tasks described in this document establishes a common framework for MLMD performance evaluation processes.
This process is to assist manufacturers to evaluate the scientific validity, the technical and clinical performance of the MLMD. It may be used for evaluating the performance to assure expected performance during post-market monitoring.
This document is applicable to the performance evaluation of all forms of MLMD, comprising ML components and, where appropriate, the integrated ML component with non-ML components. The most important factor to consider for performance evaluation is that ML provides the intended purpose and does not have unintended or unintentional effects on the safety and effectiveness of a medical device.
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