(112 days)
The Single-use Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Single-use Surgical Mask Model FE2311B
This document is a 510(k) clearance letter for a Single-Use Surgical Mask and does not contain information about the acceptance criteria or a study proving the device meets criteria in the way typically associated with AI/ML devices or clinical trials.
The document is a regulatory clearance for a physical medical device (a surgical mask), which goes through a different evaluation process than software or AI-driven diagnostics. The "acceptance criteria" for a surgical mask are typically based on material properties and performance standards (e.g., fluid resistance, particulate filtration efficiency, breathability), which are demonstrated through laboratory testing, not clinical studies with "ground truth" established by experts or MRMC studies.
Therefore, I cannot provide the requested information from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types and training set details) are relevant for evaluating AI/ML medical devices, but not for a conventional surgical mask as described in this FDA clearance letter.
§ 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.