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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

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each test. For Fluid Resistance (ASTM F1862), it mentions "29 out of 32 Pass at 120 mmHg," implying a sample size of at least 32, but it's unclear if this is the standard sample size for all performance tests. The data provenance is not specified beyond being part of a non-clinical performance test for the device. It is inherently retrospective as these are tests conducted on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as these are objective performance tests of a physical device against established industry standards (ASTM, ISO, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. These are laboratory tests with objective pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective measurement protocols and performance thresholds specified in the referenced ASTM, ISO, and CFR standards for surgical face masks.

8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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