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The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.

The Nordiwell Medical Face Mask has a flat-folded design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has earloops or tie strings to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. This is a single use, disposable device, provided non-sterile.

This document is a 510(k) Premarket Notification for a medical face mask. It does not describe an AI/ML powered medical device, but rather a physical product. Therefore, many of the requested criteria regarding AI/ML model evaluation (e.g., training set, ground truth acquisition, MRMC studies, standalone performance with human-in-the-loop, number of experts for ground truth) are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device from the provided text.

Here's the information based on the provided document:

1. A table of acceptance criteria and the reported device performance

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