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The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a single use, disposable device, provided non-sterile.

The Surgical Masks, Model IIR, are non-sterile, single use, three-layers, flat-pleated style with ear loop and nose piece.

• The inner and outer layers of the Surgical Mask are made of Non-woven Spunbond . Polypropylene for protection against fluid penetration that will not lint, teat or shred.
• . The middle layer is made of highest quality Melt Blown Polypropylene Filter for optimal filtration and breathability, meeting ASTM Level 3 performance requirements.
• . The sonically sealed ear loops are made of Polyester and Spandex to secure the mask over the user's face and mouth. They fit loosely and are attached to the mask to eliminate irritation.
• The adjustable nose piece is made of Aluminum forms strong seal for protection. .
• The Surgical Masks will be provided in Blue. The device is not made from any natural rubber latex.

The document is a 510(k) premarket notification for a Surgical Mask (K203425). It describes the device's acceptance criteria and the studies performed to demonstrate its performance.

1. Table of acceptance criteria and the reported device performance

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

For the performance tests (BFE, PFE, Resistant to synthetic blood, Differential pressure, Flame Spread), each lot tested (KZ200708005, KZ200801002, KZ200905006) had 32/32 passing results. The exact sample size per test within those 32 samples is not explicitly stated, but it implies all samples tested met the criteria. The data provenance is not explicitly stated in terms of country of origin, but the applicant is BDC Dental Corporation Ltd. in Guangzhou, Guangdong, China. The studies are non-clinical (bench testing).

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 studies are non-clinical bench tests of a physical device (surgical mask) and do not involve human interpretation or expert ground truth. The "ground truth" is established by the standardized test methods themselves.

4. Adjudication method for the test set

This information is not applicable as there is no human interpretation or subjective assessment that would require adjudication. The results are quantitative measurements against predefined criteria.

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 information is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a surgical mask and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests is established by standardized test methods (e.g., ASTM F2101-19 for BFE, ASTM F2299 for PFE, ASTM F1862 for synthetic blood resistance, EN 14683:2019+AC:2019 for Differential Pressure, 16 CFR part 1610(a) for Flame Spread, and ISO 10993 series for biocompatibility). These standards define the procedures and criteria for evaluating the physical and biological properties of the device.

8. The sample size for the training set

This information is not applicable. The device is a physical product (surgical mask) and does not involve a training set for an algorithm.

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

This information is not applicable as there is no training set for an algorithm.

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