(109 days)
The Medical Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 device, provided nonsterile.
The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch. The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a medical device called "Medical Disposable Face Masks." It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not contain information about an AI/ML-driven medical device, but rather a standard medical device (face masks).
Therefore, the specific information requested about acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable to this document. The document describes non-clinical performance testing for the physical properties and biological compatibility of face masks.
However, I can extract the acceptance criteria and reported performance for the face mask product, as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance (for Face Masks)
| Test Standard | Performance Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Fluid Resistance ASTM F1862 | 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested | 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested |
| Particulate Filtration Efficiency ASTM F2299 | ≥ 95% | ≥ 95% |
| Bacterial Filtration Efficiency ASTM F2101 | ≥ 95% | ≥ 95% |
| Differential Pressure (Delta P) EN14683 Annex C |
§ 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.