(151 days)
The Medical Face Masks 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.
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This document is a 510(k) premarket notification for a Medical Face Mask. It primarily covers regulatory information and does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it speaks to the masks' intended use for protection against microorganisms, body fluids, and particulate matter, and confirms its classification as a Class II device.
Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance related to a study.
- Sample sizes for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
This document is a regulatory clearance letter, not a study report or a technical performance specification document.
§ 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.