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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 non-sterile.

The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.

This document is a 510(k) summary for the DemeMASK Surgical Mask. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered device. Therefore, many of the requested categories related to AI device studies (like expert adjudication, MRMC studies, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance for the physical properties of the surgical mask, along with details about the studies conducted to demonstrate these properties.

1. Table of Acceptance Criteria and the Reported Device Performance (Bench Testing for DemeMASK Surgical Mask)

Biocompatibility Testing

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

• Resistance to penetration by synthetic blood (ASTM F1862): 32 samples were tested.
• Other performance tests (ASTM F2299, ASTM F2101-19, MIL-M-36954, 16 CFR 1610): The specific sample sizes are not explicitly stated in this summary for each test, but standard test methods typically involve a representative number of samples.
• Biocompatibility tests (ISO 10993-5, ISO 10993-10): Sample sizes are not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are typically bench tests performed on manufactured samples.

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

Not applicable. These are bench tests for physical properties of a surgical mask, not a device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. These are objective bench tests, not involving human adjudication of results.

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 document pertains to a surgical mask, not an AI-powered device.

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

Not applicable. This document pertains to a surgical mask, not an algorithm.

7. The type of ground truth used

For the performance tests, the "ground truth" is established by the objective measurements obtained through standardized laboratory test methods (e.g., measuring filtration efficiency, pressure differential, and synthetic blood penetration). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo (though not human clinical in this case) tests.

8. The sample size for the training set

Not applicable. This document pertains to a physical medical device (surgical mask) and not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for a surgical mask.

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