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The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.

The provided text describes the acceptance criteria and the study conducted for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: For all tests (synthetic blood penetration, BFE, PFE, Delta P, and Flammability), the sample size was 32.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only states that the tests were conducted according to established ASTM and CPSC standards.

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

This information is not applicable to a surgical mask. The "ground truth" for a device like a surgical mask is established by objective physical and chemical performance tests against predefined standards, not by expert interpretation or judgment of images or clinical data.

4. Adjudication method for the test set:

This information is not applicable. As mentioned above, the "ground truth" is based on objective measurements and predefined acceptance criteria in engineering and material science, not on expert adjudication of ambiguous cases.

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:

This information is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable. The device is a surgical mask and does not involve any algorithms or AI for standalone performance.

7. The type of ground truth used:

The ground truth used for this device is based on objective performance standards and measurements as defined by:

• ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks (which includes ASTM F1862, ASTM F2101, ASTM F2299, and Mil-M-36954C)
• CPSC 1610 for Flammability

These standards define the physical and material properties that classify a surgical mask for a particular performance level (Level 3 in this case).

8. The sample size for the training set:

This information is not applicable. The device is a physical product (surgical mask) and does not involve AI or machine learning models that require training sets.

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

This information is not applicable for the same reason as point 8.

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