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The Expanded Chamber Surgical Face Mask is 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(s), provided non-sterile.

The product is a face mask utilizing an expanded chamber design consisting of nonwoven spunbond, nonwoven meltblown, and nonwoven inside layer material, nosepiece, and nonwoven ties and may be produced with or without a visor.

This document describes the regulatory clearance for the FLUIDSHIELD* Surgical Mask with Expanded Chamber (K143287). The information provided is primarily for regulatory purposes and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics in humans.

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

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

The device is evaluated against the ASTM F2100-11 Level 2 Surgical Mask standard. The acceptance criteria are implicitly defined by this standard, and the device reports meeting these.

2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the performance tests (e.g., how many masks were tested for BFE or PFE). The data provenance is also not mentioned, as these are likely laboratory tests conducted for regulatory compliance by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes physical and biological performance testing of a surgical mask, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to established industry performance standards (ASTM F2100-11).

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

Not applicable. The performance testing of surgical masks against standards does not typically involve adjudication methods like those used in clinical studies with human readers.

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 is for 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 document is for a physical medical device (surgical mask), not an algorithm.

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

The "ground truth" used for evaluating the device's performance is adherence to established industry performance standards (ASTM F2100-11 for Level 2 surgical masks) and other relevant standards (MIL-M-36954C, ASTM F2299, ASTM F2101, 16 CFR Part 1610, ASTM F1862, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set

Not applicable. This document describes the regulation of a physical product, not a machine learning model.

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

Not applicable. This document describes the regulation of a physical product, not a machine learning model.

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