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PRIMAGARD™ Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedured to protect both the surgical patient and the operating room personnel from transfer of microcogniss is, body fluids, and particulate material. The PRIMAGARD™ Surgical Masks may also be worn outide of the operating room for non-surgical procedure use.

These surgical masks are rectangular, waterfall-pleated or soft-bill devices manufactured from selected non-woven materials (polypropylene or wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative, to the degree w of protection required during intended use.

The provided text is a 510(k) summary for a surgical mask. It describes the device, its intended use, and its technological characteristics compared to a predicate device. The document also includes an FDA letter confirming substantial equivalence.

However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data in the format of the requested table. Surgical masks are typically cleared based on performance testing against recognized standards (like ASTM F2100 for medical face masks), which measure things like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, and breathability. These are typically bench tests, not clinical studies involving human subjects in the way AI/ML devices are.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document for this type of medical device.

The document indicates that the device (PRIMAGARD™ Surgical Mask) is "technologically similar to the predicate device (K001951)" and "The PRIMAGARD™ Surgical Masks are an improvement in that non-woven materials production technologies have advanced and there is a better understanding of the physical aspects of the filtration capability. Accordingly, the non-woven products utilized in the PRIMAGARD™ Surgical Masks, when used in specific weight (gsm, grams per square meter) combinations are able to provide defined fluid resistance (as measured by the ASTM F2100-07 Standard Synthetic Blood Fluid Resistance test)."

This statement implies that the device likely meets acceptance criteria defined by standards like ASTM F2100-07 for parameters specific to surgical masks, but the actual performance data and explicit acceptance criteria are not detailed in this 510(k) summary.

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