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How We Develop AI for 510(k)-Cleared Devices by Grace Adams and Yujan Shrestha, MD on January 26, 2021 Want to know how we develop safe, effective, and FDA compliant machine learning algorithms? This article describes how we develop machine learning algorithms, points out common pitfalls, and makes documentation recommendations. When developing a machine learning or AI algorithm, it’s easy to become overly focused on making the best model possible. While model performance is important, to...