(119 days)
The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
The 3M™ High Performance Surgical Mask has a duckbill design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has ties to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. They may be produced with or without a face shield. This is a single use, disposable device, provided non-sterile.
This device is not made with Natural Rubber Latex.
The provided text is a 510(k) premarket notification for a surgical mask, which outlines its substantial equivalence to a predicate device based on performance specifications and safety. It is not a study proving device meeting acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and information as this document pertains to a physical medical device (surgical mask), not an AI/ML software device.
Key reasons why the request cannot be fulfilled based on the provided text:
- Device Type: The document is about a physical medical device (surgical mask), not a software-based AI/ML device.
- Acceptance Criteria for AI/ML: The acceptance criteria for AI/ML devices typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., and are evaluated against a ground truth established by experts. The criteria here are based on ASTM standards for surgical mask performance (e.g., fluid resistance, particulate filtration, bacterial filtration, flammability).
- Study Design: The document references "nonclinical tests" demonstrating equivalence to a predicate device based on performance specifications. This is not a description of a clinical study or a standalone AI/ML performance study as requested.
- Ground Truth, Sample Sizes, Experts, Adjudication: These concepts are relevant to studies evaluating diagnostic or predictive performance of AI/ML algorithms and are not applicable to the documentation of a surgical mask following ASTM standards.
- MRMC Comparative Effectiveness Study: Such studies compare human performance with and without AI assistance, which is not relevant for a surgical mask.
Therefore, the requested information (table of acceptance criteria with AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth types) cannot be extracted or inferred from the provided 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.