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The Procedure Masks / Surgical 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(s), provided non-sterile.

The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) Premarket Notification for a Procedure Mask/Surgical Mask. It describes the device's technical specifications and performance testing. However, it is important to note that this document is for a medical device (a mask) and not a software or AI-based device. Therefore, many of the requested elements for describing an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details, are not applicable in this context.

The document focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device by meeting certain performance criteria.

Here's the information derived from the document that is applicable to your request, formatted as closely as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against the ASTM F2100 requirements for Level 1 and Level 3 masks.

Acceptance Criteria and Device Performance for Level 1 Masks:

Acceptance Criteria and Device Performance for Level 3 Masks:

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

• Sample Size for Test Set:
  • Fluid Resistance (ASTM F1862): 32 samples per lot, across 3 lots for both Level 1 and Level 3 masks. (e.g., "32 out of 32 passed at 80 mmHg, 3 lots")
  • Particulate Filtration Efficiency (ASTM F2299): Not explicitly stated how many individual samples were tested, but results are reported as percentages for "3 lots."
  • Bacterial Filtration Efficiency (ASTM F2101): Not explicitly stated how many individual samples were tested, but results are reported as percentages for "3 lots."
  • Differential Pressure (EN 14683): Not explicitly stated how many individual samples were tested per lot, but results are reported with three values for each model (e.g., "2.9, 2.8, 2.7 mmH₂O/cm²"), likely representing different samples or averages across lots.
  • Flammability (16 CFR 1610): Not explicitly stated.
• Data Provenance: The document implies that the tests were conducted by the manufacturer or a third-party lab on samples of their manufactured masks. The manufacturer is KENPAX INTERNATIONAL LIMITED, located in Hong Kong, China. The testing therefore likely occurred in China or at a contract lab. The data is prospective in the sense that these tests were performed on new device samples to demonstrate compliance.

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 type of information is not applicable. The "ground truth" for medical masks is established by validated standardized test methods (e.g., ASTM standards) and not by expert clinical consensus. The performance is measured objectively using specified laboratory procedures.

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

Not applicable, as this is objective performance testing against a standard, not classification based on expert opinions.

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 for a physical medical device (mask), not an AI system.

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

Not applicable. This is for a physical medical device (mask), not an AI system. The tests are for the physical properties of the mask.

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

The "ground truth" is based on established engineering and materials science standards for mask performance (e.g., flow rates, particle sizes, microbial viability, fluid pressure) as defined by organizations like ASTM and EN. For example, the ground truth for Bacterial Filtration Efficiency (BFE) is derived from the established protocol of the ASTM F2101 standard, which dictates the aerosolization of Staphylococcus aureus and measurement of filtration effectiveness.

8. The sample size for the training set

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

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

Not applicable. As above, no AI model or training set is involved.

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