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The Kimberly-Clark, KC200 and KC300 Face Mask(s) 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 of the wearer to blood and body fluids. The Kimberly-Clark, KC200 and KC300 face mask(s) is a single use, disposable device(s), provided non-sterile.

The Kimberly-Clark Face Mask(s) is a four layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester. The mask is provided with earloops or ties in either knitted polyester/lycra or nonwoven polyester. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. Kimberly-Clark KC200 and KC300 Face Mask(s) will be provided with and without a protective visor. Kimberly-Clark Face Mask(s) is a single use, disposable device, provided non-sterile.

Here's a summary of the acceptance criteria and study information for the KC 200 and KC 300 Face Masks, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All results of testing met acceptance criteria." However, specific numerical acceptance criteria (e.g., "BFE > 95%") are not explicitly listed in the provided text. Instead, meeting the standards themselves serves as the acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each test (e.g., number of masks tested for BFE).
The data provenance is not specified, but it's implied to be from laboratory testing rather than human subject data or clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for these tests is established by fulfilling the objective, standardized criteria of the specified ASTM, Mil, PSC, and ISO test methods, which are laboratory-based performance measurements. No human experts are involved in establishing 'ground truth' in the context of these device performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and objective, following established protocols. No adjudication method is described or necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is not relevant for surgical face masks which are evaluated based on their physical and performance characteristics against established standards, not on human interpretation of medical images or data.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical product (face mask), not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used is based on objective performance measurements against established industry and military standards (ASTM, Mil-Spec, ISO, PSC). These standards define the acceptable physical and filtration characteristics for surgical masks.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device does not use a training set.

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