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Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.

The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.

The manufacturer, Jiangsu JianYu Health Medical Co., Ltd., submitted a 510(k) premarket notification (K201754) for their JianYu Surgical Mask. The device is classified as a Class II surgical apparel under regulation 21 CFR 878.4040. The predicate device is the "Surgical Face Mask (EL30000)" cleared under K160269.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the JianYu Surgical Mask are based on the ASTM F2100-19 Level 3 standard for medical face mask performance. The reported performance of the device is compared against these criteria, as well as against the predicate device (K160269).

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

The document does not specify the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE, synthetic blood penetration, flammability, cytotoxicity, irritation, and sensitization). However, the tests were conducted according to established international and national standards (ASTM, EN, ISO, 16 CFR), which typically outline the required sample sizes and methodologies for ensuring statistical validity.

The data provenance is from non-clinical performance testing conducted by the manufacturer or a designated testing facility, following the mentioned standards. There is no information provided regarding the country of origin of the data beyond the manufacturer's location in China. The testing is assumed to be prospective in nature, as it aims to demonstrate the device's performance against predefined criteria.

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

This submission is for a medical device (surgical mask) that is evaluated based on non-clinical performance testing against established standards, not through interpretation of complex medical cases requiring expert radiologists or other medical specialists to establish ground truth. Therefore, no medical experts were used to establish ground truth in the context of diagnostic performance. The "ground truth" for the device's performance is determined by the objective measurements and pass/fail criteria defined within the specified testing standards. The experts involved would be laboratory technicians and engineers qualified to conduct these specific tests and interpret the results according to the standards.

4. Adjudication method for the test set

As the evaluation is based on objective non-clinical performance tests against pre-defined criteria in standards, an adjudication method (like 2+1, 3+1) is not applicable. The results of each test are compared directly to the specified acceptance criteria of the relevant standard.

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

No MRMC comparative effectiveness study was done. This device is a surgical mask, not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

Not applicable. This device is a passive physical barrier (surgical mask) and does not involve any algorithms or software that would perform in a standalone or human-in-the-loop capacity.

7. The type of ground truth used

The ground truth used is based on objective measurements and pass/fail criteria defined in recognized consensus standards for medical face masks. These include:

• Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101-19.
• Differential Pressure: Measured according to EN14683: 2019 Annex C.
• Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17.
• Resistance to Penetration by Synthetic Blood: Measured according to F1862/F1862M-17.
• Flammability: Measured according to 16 CFR PART 1610.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Evaluated according to AAMI/ANSI/ISO 10993-5:2009 and AAMI/ANSI/ISO 10993-10:2010.

8. The sample size for the training set

Not applicable. Surgical masks are not data-driven systems that require a "training set." The device's performance is determined by its physical characteristics and material properties, which are evaluated through standardized laboratory tests.

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

Not applicable. As there is no training set for this type of device, no ground truth was established for a training set.

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