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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.

The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

The provided text is for a 510(k) summary for a "Surgical Mask" and details a series of non-clinical (benchtop) performance tests and biocompatibility tests. It does not describe a study involving human readers or AI assistance. Therefore, some of the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, and expert qualifications is not applicable.

Here's the breakdown of the acceptance criteria and performance data for the Surgical Mask:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

For each of the benchtop performance tests, the sample size was 96 devices, consisting of three non-sequential lots of 32 devices each. The data provenance is not specified beyond being "non-clinical performance testing" and conforming to specified standards, which typically implies laboratory testing. The country of origin of the data is not mentioned, and it is by nature prospective testing for the purpose of regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests are benchtop performance tests on physical devices, not image analysis or diagnostic studies requiring expert review for ground truth establishment.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against defined standards, not requiring adjudication of subjective interpretations.

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 submission is for a physical medical device (surgical mask), not an AI-powered diagnostic tool. No human reader or AI assistance studies were conducted or are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For the benchtop physical performance tests, the "ground truth" is defined by the objective measurement standards outlined in the listed ASTM and EN standards (e.g., specific thresholds for particulate filtration efficiency, bacterial filtration efficiency, differential pressure, synthetic blood penetration, and flammability). For biocompatibility, the "ground truth" is based on the results of validated biological tests against the criteria of ISO 10993.

8. The sample size for the training set

Not applicable. This is for a physical device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This is for a physical device, not a machine learning model.

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