(97 days)
The Disposable Medical Face Masks are 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, disposable device(s), provided non-sterile.
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This document is a 510(k) clearance letter from the FDA for a Disposable Medical Face Mask. It is not a document describing an AI/ML medical device or a clinical study for such a device.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance, as the provided text does not contain any such details relevant to an AI/ML medical device.
The document discusses the regulatory clearance process for a simple medical device (a face mask) and confirms its substantial equivalence to
legally marketed predicate devices. It covers:
- The device name and applicant.
- The FDA regulation number, name, and product code.
- The regulatory class (Class II).
- General controls provisions of the Act (e.g., registration, listing, GMP, labeling).
- Indications for Use of the face mask.
- Type of Use (Over-The-Counter Use).
None of these sections contain information related to AI/ML device performance, acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC studies.
§ 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.