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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 nonsterile.

The Surgical Face Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Surgical Face Mask around the nose. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H- phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex elastic cord and chinlon ultrasonic welded to the Surgical Face Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Surgical Face Mask is in the middle layer of Surgical Face Mask to allow the user to fit the Surgical Face Mask around their noses, which is made of steel wire and polypropylene. The Surgical Face Mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Surgical Face Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 115±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.

The provided text describes the regulatory clearance of a Surgical Face Mask (Model: METH-03) through a 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each performance test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the performance results.

• For Biocompatibility, it mentions "the subject device extract" and "the subject device non-polar and polar extracts" were tested, implying samples of the device materials were used.
• Data Provenance: The tests were conducted by a laboratory, and the methods cited are international standards (ASTM, EN, ISO, CFR). The applicant is Jiangsu Micsafe Medical Technology Co., Ltd from China, so the testing was likely overseen or conducted by labs associated with or contracted by the manufacturer, possibly in China. This is considered retrospective bench testing conducted specifically for this regulatory submission.

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

This information is not applicable as the studies are non-clinical bench tests for device performance, not clinical studies requiring expert ground truth for interpretation of medical images or patient data. The "ground truth" for these tests is defined by the objective measurement standards of the test methods (e.g., bacterial count, pressure differential, particle count, chemical reactions).

4. Adjudication method for the test set

This is not applicable as the studies are non-clinical bench tests. Adjudication typically refers to resolving discrepancies in expert interpretations in clinical settings, which is not relevant here. The tests involve objective measurements against predefined acceptance criteria.

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

An MRMC study was not done. This submission is for a surgical face mask, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

This is not applicable. The device is a surgical face mask, not an algorithm or AI system. The performance evaluated is the physical and biological integrity and filtration capabilities of the mask itself.

7. The type of ground truth used

The "ground truth" for the bench tests is based on objective, quantifiable measurements derived from standard laboratory test methodologies (e.g., bacterial challenge for BFE, defined pressure for fluid resistance, particle size and count for PFE). For biocompatibility, it's based on observable cellular responses (cytotoxicity), and immunological and dermal reactions (sensitization and irritation) according to ISO standards.

8. The sample size for the training set

This is not applicable. The device is a physical product (surgical face mask), not a machine learning model. Therefore, there is no "training set."

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

This is not applicable as there is no training set for this device.

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