(171 days)
The Surgical Face Masks, Model: EFDS-LS-Pn BLU is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable mask provided non-sterile.
Surgical Face Masks, Model: EFMDS-L50Pn BLU
This document is a 510(k) clearance letter from the FDA for a surgical face mask. It does not contain information about a medical device that uses AI or a study proving its performance against acceptance criteria. Therefore, I cannot provide the requested information.
The document discusses:
- The device name: Surgical Face Masks, Model: EFMDS-L50Pn BLU
- Its regulatory classification (Class II, Product Code FXX, Regulation Number 21 CFR 878.4040)
- Its intended use: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material... for use in infection control practices to reduce the potential exposure to blood and body fluids."
- It clarifies that it's a "single-use, disposable mask provided non-sterile."
It is a clearance based on substantial equivalence to legally marketed predicate devices, not on a performance study demonstrating AI software's accuracy.
Therefore, I cannot answer the questions about acceptance criteria, study details, expert ground truth, MRMC studies, or standalone algorithm performance, as these are not relevant to the provided text.
§ 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.