(293 days)
Disposable Face Mask is indicated as a protective nose and mouth covering for healthcare workers involved in medical and surgical procedures. The masks are indicated for use in procedure or situation where there is a risk of exposure to microorganisms and body fluids.
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It appears you've provided an FDA 510(k) clearance letter for a "Disposable Face Mask" (K203152). This document does not contain any information about acceptance criteria or a study proving that an AI/medical device meets acceptance criteria.
The 510(k) process for a disposable face mask primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves showing adherence to specific performance standards (e.g., fluid resistance, filtration efficiency) rather than AI model performance metrics.
Therefore, I cannot fulfill your request using the provided text. The document is about a low-risk medical device (a face mask) and does not involve AI or complex performance studies described by your detailed questions.
§ 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.