QAI/ML-SaMD: A Hybrid Health-Technology Quantifiable Quality Metric for Artificial Intelligence/Machine Learning-Based Software as a Medical Device.

Abstract

Background: The increasing integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices necessitates robust quality evaluation methods. However, existing approaches remain qualitative, sector-specific, or focused on isolated attributes, leaving a gap in quantifiable assessment for AI/ML-driven Software as a Medical Device (SaMD). Objective: This study introduces QAI/ML-SaMD, a novel hybrid metric that provides a comprehensive, quantifiable measure of AI/ML-SaMD qual