(122 days)
The Surgical Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of micro-organisms, body fluids and particulate material.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a face mask, not a device that utilizes AI or requires a study to prove its performance based on the provided criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."
This means the face mask was cleared based on substantial equivalence to an existing legally marketed device, not on a new study demonstrating its performance against specific acceptance criteria in the way you've outlined for AI-powered devices.
Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:
- Acceptance criteria and reported device performance: This face mask was cleared through substantial equivalence, not by meeting specific performance metrics from a new study.
- Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set size, or how ground truth was established: These are all relevant to clinical studies for new or AI-powered devices, which is not the context of this 510(k) clearance for a face mask.
The document only discusses the regulatory process for a physical device (a face mask) and its clearance based on substantial equivalence.
§ 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.