(223 days)
Surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
The Surgical Face Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of 3-ply Non-Woven material; inner and outer cover web with middle different filter web sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie string or elastic ear loop and a malleable plastic coated wire nose piece. For protection against airborne particles and splatters of blood and saliva…etc
The provided text describes a 510(k) premarket notification for a surgical face mask and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
The document discusses:
- Device identification: Surgical Face Mask, class II, product code FXX.
- Submitter and contact information.
- Date prepared and received by FDA.
- Predicate devices for substantial equivalence (3M 1818 Tie-on Surgical Mask, 3M 1818FS Tie-on Surgical Mask with Face Shield, Crosstex ® Isolite® Earloop Face Masks).
- Intended use and Indications for Use (to protect against transfer of microorganisms, body fluids, and particulate materials).
- Device description: flat, pleated, tie-on or elastic ear-loop, 3-ply Non-Woven material, malleable plastic coated wire nose piece.
- One performance mention: "According to Nelson report for the BFE (Bacteria Filtration Efficiency) up to 95% at 3.0 µm particle size." This is a single data point for one criteria, but not a full table of acceptance criteria nor a description of the study methodology.
- FDA's substantial equivalence determination letter.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory submission for a conventional medical device (surgical face mask), not an AI/ML medical device, and thus the specific questions about AI/ML device performance evaluation methods (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or addressed.
§ 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.