(191 days)
This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to spatter of blood and other infectious materials.
Not Found
This document describes the 510(k) premarket notification for 3-Layer Medical Face Masks (XMM3L3C) and 3-Layer Medical Face Masks with ties (XMM3HT).
This document does not contain information about an AI/ML-driven medical device. Instead, it is a clearance letter for standard medical face masks. Therefore, I cannot extract any information related to acceptance criteria, study details, expert qualifications, or ground truth establishment for an AI/ML device from the provided text.
The closest relevant information, though not directly applicable to an AI/ML device's performance, is the "Indications for Use" section on page 2. It states: "This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to spatter of blood and other infectious materials."
To fulfill your request for information on acceptance criteria and study proving device performance for an AI/ML device, I would need a different document that pertains to such a device.
§ 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.