(169 days)
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.
The provided text is a 510(k) summary for a surgical face mask. It indicates that no clinical tests were performed to establish acceptance criteria or to prove that the device meets those criteria. Instead, the device's substantial equivalence to a predicate device (K060776) was demonstrated through bench testing.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document states "Discussion of Clinical Tests Performed: Not Applicable". Performance targets and results from clinical studies are not provided. The substantial equivalence is based on meeting the same technological characteristics as the predicate device, which implies compliance with relevant standards through bench testing, not clinical performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned. The submission relies on "bench testing" which is typically laboratory-based and doesn't involve human subjects for performance evaluation in the way a clinical study would.
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)
Not applicable. No clinical test set requiring expert ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is mentioned.
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
Not applicable. This is a surgical face mask, not an AI-assisted diagnostic device. No MRMC study or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical face mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth is mentioned. The evaluation is based on bench testing of the product's physical and filtration properties, comparing them to established standards and the predicate device.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is mentioned.
§ 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.