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The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux.

Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation

Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.

The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

This document is a letter from the FDA regarding the clearance of a surgical mask, not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in the context of an AI/ML device.

The provided text describes the "Indications for Use" for the ProGear® Surgical Mask with Oxafence®, Model AV82030, and lists the antiviral efficacy against specific viruses in laboratory (in vitro) tests. This information pertains to the performance of the physical device as a surgical mask, not a software or AI/ML product.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device from this document.

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