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Surgical 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. Surgical Face Masks are single use, disposable devices, provided non-sterile.

Surgical Face Mask contains one model called YOD2001. YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type. YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of polypropylene to provide a firm fit over the nose.

This document is a 510(k) Premarket Notification for a Surgical Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and effect size) are not applicable or provided in this document.

However, I can extract information related to the performance testing of the physical surgical mask against established standards.

Acceptance Criteria and Device Performance (for the physical mask):

The acceptance criteria are derived from ASTM F2100 - Level 2 standards. The reported device performance indicates that the Surgical Face Mask met all these criteria.

Regarding AI/ML Specific Criteria (which are not applicable to this document):

1. Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for a physical mask, not an AI/ML algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the mask is based on standardized physical and material tests, not expert interpretation of outputs.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device is based on established laboratory testing standards (e.g., ASTM, EN, ISO) for physical properties, filtration efficiency, fluid resistance, flammability, and biocompatibility.
7. The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (for the physical mask):

The device underwent non-clinical performance testing and biocompatibility testing.

• Non-Clinical Performance Test: The mask was tested for Bacterial Filtration Efficiency (BFE), Differential Pressure (Delta-P), Sub-Micron Particulate Filtration Efficiency (PFE), Resistance to Penetration by Synthetic Blood, and Flammability. The specific test methods (ASTM F2101, EN 14683 Annex C, ASTM F2299, ASTM F1862, 16 CFR Part 1610) and acceptance criteria for Level 2 masks were applied. The device "Passed" all these tests.
• Biocompatibility Testing: Based on ISO 10993-1:2018, tests for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), and Skin Irritation (ISO 10993-10) were conducted since the device contacts intact skin for less than or equal to 24 hours. The results for all these tests indicated "Non-cytotoxic," "Non-sensitizing," and "Non-irritating" respectively.

Data Provenance: The document does not explicitly state the country of origin for the test data, nor whether the tests were retrospective or prospective. However, tests following established international and US standards (ASTM, EN, ISO, CFR) are inherently prospective performance evaluations. No clinical study was included in this submission.

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