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A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for an "Earloop Procedure Mask", which primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

It details:

• The applicant, device name, regulation number, and classification.
• The FDA's review and determination of substantial equivalence.
• General controls and additional controls that may apply to the device.
• Contact information for specific advice from the FDA.
• The "Indications for Use" for the surgical mask, stating its purpose to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate materials.
• A checkbox indicating "Over-The-Counter Use".

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or ground truth establishment.
• Details about expert involvement, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set details.

Therefore, I cannot fulfill your request based on the provided text.

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