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The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.

This document describes the premarket notification (510(k)) for a Medical Face Mask, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is for a physical medical device (a face mask) and not an AI/ML-driven device. Therefore, many of the requested details about AI model performance, training sets, ground truth establishment by experts, adjudication, and MRMC studies are not applicable to this document.

However, I can extract and present the acceptance criteria and the study results for this specific medical device.

Device: Medical Face Mask (K212471)
Predicate Device: Surgical Face Masks (Ear loops and Tie-on) (K160269)

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are "Pass" for all tests, with specific quantitative thresholds where applicable. The reported device performance is that all tests met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (e.g., number of masks) used for each specific performance or biocompatibility test. It mentions that "All of the tested parameters met the predefined acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance.

The data provenance is implied to be from testing conducted by Haian Medigauze Co., Ltd. in China, as they are the submitter. The data is retrospective, as it's being submitted for premarket notification of a completed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as this is a physical medical device (face mask) and not an AI/ML-driven device that requires expert ground truth for its performance evaluation (e.g., image interpretation). The "ground truth" for the face mask is established by validated laboratory test methods and established international standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Performance is determined by objective, measurable laboratory tests, not by human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This question is not applicable as this is not an AI-assisted diagnostic device or a device where human reader performance is a relevant metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as this is not an AI/ML algorithm. The "standalone" performance refers to the intrinsic physical properties and filtration capabilities of the face mask itself, as measured by standard laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective laboratory measurements against predefined performance standards (e.g., ASTM F2100-19 for filtration efficiency, differential pressure, flammability, and resistance to synthetic blood penetration; ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for this type of device.

8. The Sample Size for the Training Set

This question is not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" process with a dataset.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

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