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The 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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and provided non-sterile.

The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Surgical Mask (K211552):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fluid Resistance (ASTM F1862/F1862M-17): The acceptance criteria states "29 out of 32 pass", implying a sample size of 32 units were tested for fluid resistance.
• Other performance tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): The document does not explicitly state the sample sizes for these tests, only that the device "Passed" the criteria. Typically, standards like those referenced (ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) would specify minimum sample sizes.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The document does not explicitly state the sample size for the biocompatibility tests (in vitro cytotoxicity, irritation, skin sensitization). However, the results are presented as having been performed on the "test article extract" and "applied sample," which refers to the surgical mask material.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only states that "Performance testing including biocompatibility evaluation was performed on the final finished device" and refers to the device being manufactured in China.

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 document describes the testing of a medical device (surgical mask) against established performance standards and biocompatibility guidelines. These tests are typically conducted in accredited laboratories by qualified technicians and scientists according to the specified protocols. There is no mention of "experts" in the sense of medical professionals diagnosing or interpreting results (like radiologists for imaging studies) or establishing a subjective "ground truth" through consensus. The ground truth for these tests is defined by the objective measurement criteria and methods specified in the referenced ASTM, ISO, EN, and CFR standards.

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

Not applicable. This device is a medical product (surgical mask) whose performance is evaluated through objective physical and biological tests against predetermined technical standards, not through subjective interpretation by experts that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to the regulatory clearance of a surgical mask, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.

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

Not applicable. This device is a medical product (surgical mask), not an algorithm or AI system.

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

The "ground truth" for the device's performance is established by the objective, quantitative measurements and qualitative observations obtained through validated test methods outlined in the referenced standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for bacterial filtration, ISO 10993 for biocompatibility). These standards define the acceptable performance characteristics for a surgical mask.

8. The sample size for the training set:

Not applicable. This document describes the testing and regulatory submission for a physical medical device (surgical mask), not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no "training set" for this physical medical device, there is no ground truth established for one.

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