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The PMW01 Procedure Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

PMW01 Procedure Mask Level 1

The provided text is a U.S. FDA 510(k) clearance letter for the PMW01 Procedure Mask Level 1. This document confirms the device's substantial equivalence to previously marketed devices. However, this type of document does not contain information about acceptance criteria for device performance, the results of studies proving these criteria are met, sample sizes, expert qualifications, or ground truth establishment.

Instead, the FDA 510(k) clearance process primarily evaluates whether a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. For medical masks, this typically involves testing against recognized industry standards such as ASTM F2100 to show performance levels (e.g., Level 1, 2, or 3).

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth. These details would typically be found in a separate submission document or a summary of safety and effectiveness, which are not part of the clearance letter itself.

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