(81 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that 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. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.