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The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)

Device Description

The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single-use only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.

AI/ML Overview

The KNH Surgical Face Mask (Models 1MMAB50DM2 (Level 1) and 1MMAB50DM3 (Level 2)) underwent non-clinical testing to demonstrate substantial equivalence to the predicate device K160269. The acceptance criteria and reported device performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Purpose	Acceptance Criteria	Reported Device Performance	Result
Fluid Resistance ASTM F1862	To ensure adequate resistance to fluids	1MMAB50DM2 (Level 1): At least 29/32 pass at 80 mmHg for three non-consecutive lots
1MMAB50DM3 (Level 2): At least 29/32 pass at 120 mmHg for three non-consecutive lots	Pass	Pass
Particulate Filtration Efficiency ASTM F2299	To demonstrate adequate resistance to particulate transmission	1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots
1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots	Pass at Avg. 99.49 % (Level 1)
Pass at Avg. 99.31% (Level 2)	Pass
Bacterial Filtration Efficiency ASTM F2101	To demonstrate adequate resistance to bacterial penetration	1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots
1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots	Greater than 99% (Level 1)
Greater Than 99% (Level 2)	Pass
Differential Pressure Mil M36945 Appendix C	To demonstrate adequate breathability	1MMAB50DM2 (Level 1): At least 29/32 pass at 5 mmH₂O/cm² or less for three non-consecutive lots
1MMAB50DM3 (Level 2): At least 29/32 pass at 6 mmH₂O/cm² or less for three non-consecutive lots	Pass at 2.5 to 2.9 mmH₂O/cm² (Level 1)
Pass at 2.7 to 3.7 mmH₂O/cm² (Level 2)	Pass
Flammability 16 CFR 1610	To demonstrate adequate flammability resistance	At least 29/32 samples at class 1	Class 1	Pass
Biocompatibility Skin Sensitization ISO 10993-10	To demonstrate low skin sensitization potential	Under the conditions of the test, not a sensitizer	Under the conditions of the study, not a sensitizer	Pass
Biocompatibility Skin Irritation 10993-10	To demonstrate low skin irritation potential	Under the conditions of the test, not an irritant	Under the conditions of the study, not an irritant	Pass
Biocompatibility Cytotoxicity 10993-5	To demonstrate low cytotoxicity	Under the conditions of the test, non-cytotoxic	Under the conditions of the study, non-cytotoxic	Pass

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

The document states criteria like "At least 29/32 pass at [value] for three non-consecutive lots" for several tests. This implies that for each of these tests, a sample size of 32 units per lot was used, and this was repeated for at least three non-consecutive lots. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, as these are technical performance tests on the manufactured device itself, rather than clinical data from human subjects.

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

Not applicable. This submission is for a surgical face mask and relies on objective, standardized laboratory performance tests according to established ASTM, Mil, and ISO standards, not expert interpretation of subjective data or images.

4. Adjudication method for the test set:

Not applicable. As noted above, the tests are objective laboratory performance measures with predefined pass/fail criteria, not subjective assessments requiring expert 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 submission for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This is not an algorithmic or software-based device.

7. The type of ground truth used:

The ground truth for device performance is established by objective, standardized measurements against predefined values and criteria as specified in the referenced ASTM, Mil, and ISO standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency, ASTM F2101 for bacterial filtration efficiency, Mil-M-36945C Appendix C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993-5 and ISO 10993-10 for biocompatibility).

8. The sample size for the training set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The manufacturing process and material selection are validated through quality control and adherence to standards.

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

Not applicable. There is no training set for this type of device. The quality and performance are established through adherence to manufacturing specifications and testing against recognized industry standards.

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