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Disposable Face Mask is indicated as a protective nose and mouth covering for healthcare workers involved in medical and surgical procedures. The masks are indicated for use in procedure or situation where there is a risk of exposure to microorganisms and body fluids.

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It appears you've provided an FDA 510(k) clearance letter for a "Disposable Face Mask" (K203152). This document does not contain any information about acceptance criteria or a study proving that an AI/medical device meets acceptance criteria.

The 510(k) process for a disposable face mask primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves showing adherence to specific performance standards (e.g., fluid resistance, filtration efficiency) rather than AI model performance metrics.

Therefore, I cannot fulfill your request using the provided text. The document is about a low-risk medical device (a face mask) and does not involve AI or complex performance studies described by your detailed questions.

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