(22 days)
Perfetta Moderate Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene. The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex. A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose. The subject device is provided in blue color. The blue colorant is made of polypropylene master batch. This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable device, provided non-sterile.
The provided text is related to the FDA 510(k) premarket notification for a medical face mask, not an AI/ML medical device. Therefore, a direct response to your detailed questions regarding acceptance criteria, study design for AI/ML devices, and ground truth establishment is not applicable. The information describes the performance testing of a physical product (medical face mask) against established industry standards.
However, I can extract the acceptance criteria and the device's performance based on the provided document as it pertains to the Perfetta Moderate Medical Face Mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥29 out of 32 passed in 120 mmHg (Level 2) | ≥29 out of 32 passed in 120 mmHg (Level 2) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% at 0.1µm | ≥98% at 0.1µm | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) |
§ 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.