(189 days)
The Disposable medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Disposable Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric with blue color. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric with white color. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
The provided text is a 510(k) Premarket Notification from the FDA for a Disposable Medical Face Mask. It outlines the device's characteristics, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Based on the provided information, I can answer some of your questions, but many of the specific details you requested (especially regarding AI/ML models, expert ground truth, and human reader studies) are not applicable as this document pertains to a physical medical device (a face mask) and not a software-based diagnostic or AI-powered system.
Here's the breakdown:
Acceptance Criteria and Device Performance (for a Medical Face Mask)
The acceptance criteria are essentially the performance requirements for medical face masks as defined by the listed ASTM and EN standards. The "device performance" is whether the mask meets these criteria.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (typically from ASTM F2100-19 for Medical Face Masks) | Reported Device Performance (Proposed Device K202628) | Predicate Device Performance (K173062) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass at 120mmHg (Level 1, 2 or 3) | Pass at 120mmHg | Pass at 120mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% (Level 2 or 3) | ≥98% | Average 99.4% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥98% (Level 2 or 3 for 0.1µm particles) | ≥98% | Average 99.74% at 0.1µm |
| Differential Pressure (Delta P) (EN 14683) |
§ 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.