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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 ininfection control practices to reduce the potential exposure to blood and body fluids.This is a single use, disposable device(s), provided non-sterile.

Device Description

The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene .iron and zinc. The proposed device(s) are sold nonsterile and are intended to be single use, disposable device.

AI/ML Overview

This document describes the acceptance criteria and the study proving that the "Surgical Face Mask (L 175*95mm)" device meets those criteria.

Table of Acceptance Criteria and Reported Device Performance:

Item	Purpose	Acceptance Criteria	Reported Device Performance	Result
Fluid Resistance ASTM F1862	Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure	29 out of 32 pass at 120 mmHg for Level 2	32 out of 32 pass at 120 mmHg	PASS
Particulate Filtration Efficiency ASTM F2299	Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron	≥ 98%	Lot1: 98.21%, Lot2: 98.21%, Lot3: 98.16%	PASS
Bacterial Filtration Efficiency ASTM F2101	Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism	≥ 98%	Lot1: 98.21%, Lot2: 98.24%, Lot3: 98.20%	PASS
Differential Pressure (Delta P) EN 14683 Annex C	Assess the performance of a mask for resistance to air movement through the materials of the face of the mask	< 6.0mmH2O/cm²	Lot1: 2.52 mmH2O/cm², Lot2: 2.60 mmH2O/cm², Lot3: 2.60 mmH2O/cm²	PASS
Flammability 16 CFR 1610	Assess the resistance of a mask to ignition	Class I	Class I	PASS
Cytotoxicity	Assess the potential risk of Cytotoxicity of mask material	Non-Cytotoxic	Non-cytotoxic	PASS
Irritation	Assess the potential risk of Irritation of mask material	Non-Irritating	Non-irritating	PASS
Sensitization	Assess the potential risk of Sensitization of mask material	Non-Sensitizing	Non-sensitizing	PASS

Sample Size Used for the Test Set and Data Provenance:
- For performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): 3 non-consecutive lots were tested, with a sample size of 32 per lot. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided document, but it represents samples from the manufactured product.
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The sample size is not explicitly stated as a number of devices/lots, but the tests were conducted on the "mask material" and "device components". The provenance is not explicitly stated.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. The tests conducted are objective, standardized laboratory tests measuring material properties and performance against established criteria, not subjective expert interpretations requiring a ground truth established by experts.
Adjudication Method for the Test Set: Not applicable. These were objective laboratory tests with quantitative or qualitative (Pass/Fail) results based on specific measurement protocols and acceptance thresholds.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done: No, an MRMC comparative effectiveness study was not done. The device is a surgical face mask, and performance is evaluated through material and physical property testing, not through human reader interpretation of medical cases.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done: Yes, the device's performance was evaluated in a "standalone" manner, meaning the device itself was subjected to physical and biological tests in a laboratory setting without human intervention beyond conducting the tests and measurements.
The Type of Ground Truth Used: The "ground truth" for the performance evaluation is based on established international and national standards for medical face masks and medical device biocompatibility. These include:
- ASTM F2100 (Standard Specification for Performance of Materials Used In Medical Face Masks)
- ASTM F1862 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
- EN 14683 (Medical Face Masks-Requirements and Test Methods)
- ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
- ASTM F2299 (Determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres)
- 16 CFR 1610 (Standard for the Flammability of clothing textiles)
- ISO 10993-5 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization)
The Sample Size for the Training Set: Not applicable. This device is a physical product (surgical face mask) and not an AI/machine learning algorithm requiring a training set.
How the Ground Truth for the Training Set Was Established: Not applicable, as there is no training set for this type of device.

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