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The CAREWE Surgical Face Masks Models N001-AW, N002-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. The masks are single-use and disposable.

The CAREWE Surgical Face Masks Models N001-AW, and N003-AW are flat-folded, single-use, disposable face masks which cover the user's nose and mouth. The mask is held in place by two elastic nylon ear loops ultrasonically bound to the mask, which attach to the user's ears. The mask is white. The CAREWE Surgical Face Mask consists of 4 ultrasonically bound layers: 1) an outer layer made of hydrophobic non-woven polypropylene; 2) a middle-layer made of polyester fiber; 3) a medium composed of melt-blown polypropylene; and 4) an inner-layer made of hydrophilic non-woven polypropylene. The mask also features a polyurethane (PU) nose pad which is attached to the mask's interior (on the hydrophilic layer). The mask meets ASTM F2100 Level 2 standards. The design, configuration, materials, and production process are all the same for all three proposed models N001-AW, N003-AW, N003-AW. They are all manufactured with the same technical specifications. The models are labeled differently strictly for marketing, sales and logistic reasons only.

The information provided pertains to the FDA 510(k) clearance for CAREWE Surgical Face Masks. This document describes non-clinical performance tests for the device, not a study evaluating an AI algorithm. Therefore, many of the requested categories regarding AI-specific studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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