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Another commenter explained that a 510(k) device can sometimes be superior to a PMA device for the same indication despite the less rigorous approval process, due to technological advancements, improved materials and design, real-world data, and improved usability and safety features

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Leave-one-out cross-validation was applied to the training dataset for choosing the optimal regularization parameter λ through minimization of the cross-validation classification error using the ‘cv.glmnet’ function

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