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The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, 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 ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.

This document is a 510(k) summary for a Disposable Surgical Mask (K202580), comparing it to a predicate device (DemeMASK, K201479). The information provided focuses on non-clinical performance testing to demonstrate substantial equivalence, rather than a study involving an AI-powered medical device or human readers.

Therefore, many of the requested details related to AI performance, human reader studies, and expert adjudication are not applicable to this document. The device in question is a physical product (surgical mask), not a diagnostic algorithm or imaging system requiring such analyses.

Here's a breakdown of the requested information based on the provided document:

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

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

• Sample Size for Resistance to penetration by synthetic blood: 32 samples were tested.
• Data Provenance: The document does not explicitly state the country of origin of the testing data itself, but the manufacturer is based in China (Qingdao Likangyuan Medical Device Co., Ltd.). The studies are inherently prospective as they are tests performed on manufactured samples to meet regulatory requirements.

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

Not applicable. This is a physical product and the "ground truth" is established through standardized laboratory test methods (e.g., ASTM, MIL-M, ISO standards) rather than expert consensus on diagnostic images.

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

Not applicable. As described above, this involves laboratory testing against established specifications, not human interpretation requiring adjudication.

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 a physical medical device (surgical mask), not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the surgical mask is defined by industry standards and regulatory requirements (e.g., ASTM, MIL-M, ISO standards) for parameters like fluid resistance, filtration efficiency, and flammability. The device's performance is measured against the specified thresholds in these standards.

8. The sample size for the training set

Not applicable. This is a manufactured product, not a machine learning model that requires a "training set."

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

Not applicable.

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