(291 days)
Naton Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, There are 4 types of Naton Disposable Surgical Face Mask: Ear Loops B-1, Tie-on B, Tie-on B-1, which are provided sterile.
Naton Disposable Surgical Face Mask
The provided document describes the FDA 510(k) clearance for the Naton Disposable Surgical Face Mask. This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, especially not for an AI/ML medical device.
The information requested in your prompt (AI/ML device performance, sample sizes, expert qualifications, ground truth, MRMC studies, etc.) is specifically pertinent to the evaluation of AI/ML-based medical devices. The Naton Disposable Surgical Face Mask is a physical product (a Class II surgical apparel), and its testing and approval process would involve different criteria, such as:
- Fluid resistance: (e.g., synthetic blood penetration)
- Particulate filtration efficiency (PFE): (how well it filters airborne particles)
- Bacterial filtration efficiency (BFE): (how well it filters bacteria)
- Breathability: (differential pressure)
- Flammability: (spread of flame)
- Biocompatibility: (skin irritation, sensitization)
Therefore, I cannot fulfill your request as the provided text does not contain the necessary information about an AI/ML medical device test study.
If you have a document describing the regulatory submission and study results for an AI/ML medical device, please provide that text, and I would be happy to analyze it according to your requested parameters.
§ 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.