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The 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Device Description

The Surgical Face Mask is 4 ply Flat Pleated type mask, utilizing ear loops for wearing, and it has nose band design for fitting the face mask around the nose. The Surgical Face Mask is manufactured with four layers. The first and second layers are made of polypropylene (PP) non-woven fabric with green coloration. The third layer has filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The fourth layer (inner layer) contacting with face is made of polypropylene (PP) non-woven fabric without color. The functions of the four layers are as follows, 1st Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 2nd Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration. 3rd Layer: Electrostatic-induced melt-blown polypropylene, blocks dust and microbes. 4th Layer: PP non-woven fabric, provides soft feel and reinforces spray and droplet protection. The Surgical Face Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon. The nose band, made of steel wire coated with Polyethylene resin, contained in the subject device is in the layers of face mask to allow the user to fit the face mask around their nose. The Surgical Face Masks are sold non-sterile and are intended to be singleuse. The size of the face mask is 175 mm * 95 mm.

AI/ML Overview

This document describes the non-clinical performance testing of the "Surgical Face Mask" manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd. (K212863), to demonstrate its substantial equivalence to a legally marketed predicate device (K201549).

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

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

Item	Test method (Performance Level 3)	Purpose	Acceptance criteria (ASTM F2100-20)	Reported Device Performance (Test results / Verdict)
1	EN 14683:2019+AC:2019(E), Annex C	Evaluate the mask's resistance to airflow across the face mask (Differential pressure, Delta-P)	Section 9.2: < 6 mm H₂O/cm²	< 5 mm H₂O/cm² / Pass
2	ASTM F1862/F1862M-17	Evaluate the mask's resistance to penetration by synthetic blood	Section 9.4: No penetration at 160 mmHg	No penetration at 160 mmHg / Pass
3	ASTM F2299/F2299M-03 (2017)	Evaluate the efficiency of material used in medical face masks to penetration by particulates using latex spheres (Particulate Filtration Efficiency)	Section 9.3: ≥ 98%	≥ 99.8 % / Pass
4	16 CFR Part 1610 (as amended in 2008)	Evaluate the mask's flammability when exposed to a direct source of ignition	Section 9.5: Class 1	Class 1 / Pass
5	ASTM F2101-19 (Bacterial filtration efficiency, BFE)	Evaluate the efficiency of material used in medical face masks to penetration by bacterial organisms	Section 9.1: ≥ 98%	≥ 99.8 % / Pass

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

Sample Size: Each test was performed using 3 nonconsecutive lots of 32 samples each, for a total of 96 samples.
Data Provenance: The document does not explicitly state the country of origin where the testing was physically conducted or whether it was retrospective or prospective. However, the manufacturer is Taiwan Comfort Champ Manufacturing Co., Ltd., based in Taiwan. The testing is for a premarket notification (510(k)), implying it was conducted specifically for this submission, which typically aligns with prospective testing for the purpose of demonstrating device performance against established standards.

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

This document describes the testing of physical properties of a surgical face mask against established industry standards (ASTM, EN, CFR). This is not an AI/ML device, and therefore, there is no "ground truth" derived from expert consensus like in image interpretation studies. The "ground truth" here is the pass/fail criteria defined by the relevant performance standards.

4. Adjudication method for the test set

Not applicable. As this is a performance test for physical properties of a device against objective standards, there is no human adjudication process involved in the results of the tests. The results are quantitative measurements against defined thresholds.

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 medical device clearance for a surgical face mask, not an AI/ML-based diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this study are the established performance criteria and specifications provided by recognized standards such as ASTM F2100-20, EN 14683:2019+AC:2019(E), ASTM F1862/F1862M-17, ASTM F2299/F2299M-03, 16 CFR Part 1610, and ASTM F2101-19. The biological evaluation (biocompatibility) also references ISO 10993 standards. These are objective, measurable criteria for the physical and biological characteristics of the mask.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As no training set is used for this type of device, this question is not relevant.

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