(449 days)
The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).
The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux.
Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation
Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.
The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).
This document is a letter from the FDA regarding the clearance of a surgical mask, not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in the context of an AI/ML device.
The provided text describes the "Indications for Use" for the ProGear® Surgical Mask with Oxafence®, Model AV82030, and lists the antiviral efficacy against specific viruses in laboratory (in vitro) tests. This information pertains to the performance of the physical device as a surgical mask, not a software or AI/ML product.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device from this document.
§ 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.