Search Results

PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

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

This document is a 510(k) premarket notification for a surgical mask (PRIMAGARD Delta Surgical Mask, K092012) and, as such, does not describe the acceptance criteria, specific study details, or performance results in the way a clinical study report or a detailed validation study would.

The provided text focuses on the regulatory submission process, declaring substantial equivalence to a predicate device (K081633), and outlining the intended use and technological characteristics.

Therefore, most of the information requested in your prompt (1-9) about acceptance criteria and study details cannot be extracted directly from this 510(k) summary and the accompanying FDA letter.

However, based on the context of a surgical mask 510(k) submission, we can infer some general points and identify what is not present:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. For surgical masks, acceptance criteria would typically relate to standardized tests مثل (but not limited to) bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), differential pressure (breathability), fluid resistance, and flammability. The document only mentions "optimal breathability, particulate filtration and a fluid-penetration barrier" as design goals but provides no specific quantitative criteria or performance data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided document. The device is a physical product (surgical mask), not an AI/diagnostic tool requiring expert-established ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present and is not applicable for a physical product like a surgical mask.

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 present and is not applicable. MRMC studies are relevant for diagnostic devices (e.g., AI algorithms for interpreting medical images), not for surgical masks. There is no AI component mentioned or implied for this device.

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

This information is not present and is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present. For surgical masks, "ground truth" would correspond to the results of standardized biological, physical, and chemical tests to measure barrier properties and breathability, not expert consensus on medical images or pathology.

8. The sample size for the training set

This information is not present and is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not present and is not applicable for the reasons mentioned in point 8.

Ask a specific question about this device