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The banded face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Banded Face Mask

This is a 510(k) clearance letter for a Banded Face Mask, which is a physical device, not an AI or software-as-a-medical-device (SaMD). Therefore, the typical acceptance criteria and study designs applicable to AI devices (such as those involving performance metrics like sensitivity, specificity, AUC, and human-in-the-loop studies) are not relevant here.

The document focuses on substantial equivalence to predicate devices for regulatory clearance, based on the physical properties and intended use of the face mask. It does not contain information about the performance criteria you've asked for in the context of an AI device.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device based on this document.

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