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

The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use. The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.

This is a 510(k) premarket notification for a medical device (Single-use Medical Face Mask), not an AI/ML-enabled device. Therefore, many of the requested categories for AI/ML study design and performance evaluation are not applicable.

However, I can extract the acceptance criteria and performance data for the medical face mask as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: For the performance tests (Flammability, BFE, Differential Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by Synthetic Blood), the study used 3 non-consecutive lots, with 32 samples per lot. The total number of samples tested for each of these performance criteria is 96 (3 lots x 32 samples/lot).
• Data Provenance: The document does not specify the country of origin of the data providers or if the data was retrospective or prospective, as these are not typically relevant for the physical performance testing of a medical mask. This information is usually provided by the manufacturer based on their internal testing protocols.

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

• Not applicable. This is a medical device (face mask) with physical performance criteria, not an AI/ML-enabled device where expert human ground truth is established for image interpretation or diagnosis. The "ground truth" is determined by objective laboratory testing against established standards (ASTM F2100).

4. Adjudication Method for the Test Set

• Not applicable. As described above, the "ground truth" is determined by objective laboratory measurements against predefined thresholds, not by human expert consensus or adjudication.

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

• Not applicable. This is a medical device (face mask), not an AI/ML-enabled device requiring a clinical MRMC study.

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

• Not applicable. This is a medical device (face mask) with physical performance, not an AI/ML algorithm. The "standalone performance" is the direct physical testing of the mask's material properties.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance is established by objective laboratory measurements against recognized international standards and specifications (primarily ASTM F2100-19 and 16 CFR 1610 for flammability), as well as biocompatibility testing standards for cytotoxicity, irritation, and sensitization. These standards define the acceptable range or threshold for each performance characteristic.

8. The Sample Size for the Training Set

• Not applicable. This is a manufactured medical device, not an AI/ML model that requires a training set of data. The manufacturing process involves quality control and testing, but not "training" in the AI sense.

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

• Not applicable. See point 8.

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