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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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, provided non-sterile.

The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document is a 510(k) summary for a Surgical Face Mask and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information related to an AI/ML powered device, comparative effectiveness studies (MRMC), or clinical studies with human readers. Therefore, several requested sections, such as those pertaining to AI/ML, human expert involvement, and ground truth establishment from clinical data, are not applicable based on the provided text.

Here’s an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Surgical Face Mask, and the performance is evaluated based on ASTM and EN standards relevant to such masks. There are three levels of surgical face masks (Level 1, Level 2, and Level 3), each with specific acceptance criteria. The test results consistently show that the device "PASS"es all specified criteria.

Level 1 Surgical Face Mask (Model: SQ-1001)

Level 2 Surgical Face Mask (Models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H)

Level 3 Surgical Face Mask (Models: SQ-3001, SQ-3001H)

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

• Test Set Sample Size:
  • For Fluid Resistance (ASTM F1862), the acceptance criteria specify "29 out of 32 pass." This indicates a sample size of 32 units tested for this particular criterion.
  • For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, the sample size is not explicitly stated numerically, but it is indicated that "3 nonconsecutive lots tested" for fluid resistance, and the results for these tests are simply "PASS." This implies that sufficient samples from those lots were tested to demonstrate compliance.
  • For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the exact number of samples is not provided, but the stated results confirm the device's acceptable biological response.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to demonstrate compliance with international standards (ASTM, EN, ISO, CFR). The document originates from Rizhao Sanqi Medical & Health Articles Co., Ltd., located in Shandong Province, China. The data is thus from laboratory testing performed in association with the manufacturer, presumably in China. The studies are retrospective in the sense that they are conducted on manufactured devices to prove compliance.

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

This information is not applicable as the device is a physical product (surgical face mask) and the testing performed is non-clinical performance and biocompatibility testing according to established standards. There is no "ground truth" derived from expert interpretation of data or images in the context of an AI/ML device.

4. Adjudication Method for the Test Set

This is not applicable as the evaluations are objective laboratory tests against predefined physical and chemical performance standards, not subjective interpretations requiring 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

This is not applicable. The submission is for a surgical face mask, not an AI/ML software device.

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

This is not applicable. The submission is for a surgical face mask, not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by objective performance specifications defined in recognized national and international standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define measurable thresholds for attributes like fluid resistance, filtration efficiency, differential pressure, flammability, and biological safety. The device performance is directly measured against these established quantitative and qualitative criteria.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI/ML software that requires a training set.

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

This is not applicable. The device is a physical product, not an AI/ML software.

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