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The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.

The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.

The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The document provided is a 510(k) Pre-market Notification for a Surgical Face Mask (Non-sterile). It outlines the non-clinical testing performed to establish substantial equivalence to a predicate device. This type of submission relies on performance testing against established standards rather than clinical studies for device functionality.

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

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Performance Tests: For Bacterial Filtration Efficiency, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flammability, 3 non-consecutive lots were tested, with a sample size of 32 per lot.
• Sample Size for Biocompatibility Tests: The exact sample size for cytotoxicity, irritation, and sensitization tests is not specified, but the tests were performed on the mask material.
• Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the applicant is from China (Xiantao Junhui Plastic Products Co., Ltd.), it is highly probable that the testing was conducted in China or a region following these international standards. The testing is non-clinical performance testing rather than human subject data.

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 section is not applicable. The device is a surgical face mask, and its performance is evaluated through standardized non-clinical laboratory tests (e.g., filtration efficiency, breathability, fluid resistance, flammability, biocompatibility) based on criteria defined in established standards (ASTM, EN, ISO, CFR). There is no "ground truth" in the clinical sense established by human experts for these types of tests. The "ground truth" is the objective measurement against the specified standard's criteria.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to methods used to resolve discrepancies among multiple expert readers or scorers, typically in medical imaging or clinical trials. As stated above, the device performance is determined by objective laboratory measurements against predefined standards.

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

This section is not applicable. MRMC studies and AI assistance are relevant to diagnostic or interpretation devices, particularly in medical imaging. The device in question is a surgical face mask, which does not involve human readers interpreting data or AI assistance.

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

This section is not applicable. "Standalone performance" or "algorithm only" refers to the performance of an AI or software algorithm without human intervention, again typically for diagnostic or interpretative devices. The surgical face mask does not use an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements against established international and national standards. For example:

• For Bacterial Filtration Efficiency, the ground truth is the measured percentage of bacteria filtered, compared against the ≥98% standard.
• For Resistance to Penetration by Synthetic Blood, the ground truth is the number of samples passing the test at 160 mmHg, compared against the 29 out of 32 pass standard.
• For Biocompatibility, the ground truth is determined by the results of standardized tests for cytotoxicity, irritation, and sensitization, compared against criteria like "non-cytotoxic," "negligibly irritating," and "non-sensitizing."

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (a surgical face mask) and does not involve machine learning or AI, and therefore no training set.

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

This section is not applicable for the same reason as point 8.

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