(195 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. These mask are 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 proposed devices are single use, three-layer, flat masks with ear-loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the outer layer is made of PPSB non-woven fabric, which the chemical composition is the mixture of Polypropylene and color master batch. Inner layer is made of Polyethylene, polypropylene and mixture of fiber finishes. And the middle layer is made of melt blown polypropylene filter. The model of proposed device ,YX001, is held in place over the user's mouth and nose bu two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The colorants used for mask are Copper phthalocyanine and Titanium dioxide.
This document does not describe an AI medical device study. It is a 510(k) summary for a Disposable Medical Face Mask (K202439), demonstrating substantial equivalence to a predicate device (K153496).
Therefore, I cannot provide information on:
- Acceptance criteria and device performance for an AI/ML model
- Sample size for a test set or data provenance in the context of AI
- Number of experts or their qualifications for ground truth in AI
- Adjudication methods for AI test sets
- MRMC studies or effect sizes for AI assistance
- Standalone AI performance
- Training set details for AI
- How ground truth for a training set was established for AI
The document focuses on non-clinical performance characteristics of the medical face mask, such as:
- Resistance to penetration by synthetic blood
- Sub-micron particulate filtration efficiency (PFE)
- Bacterial Filtration Efficiency (BFE)
- Differential Pressure (breathability)
- Flame spread
- Biocompatibility (Cytotoxicity, Irritation, Sensitization)
The acceptance criteria and performance data are entirely related to these physical and biological characteristics of a face mask, not an AI/ML algorithm.
Here is the relevant information from the document as it pertains to the face mask, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance (for the face mask):
| Items | Acceptance Criteria | Subject Device Test Result (K20249) | Predicate Device (K153496) | Purpose/Test Standard |
|---|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg, Pass at 160 mmHg | Evaluate protection against fluid penetration. |
| Sub-micron particulate filtration efficiency (PFE) (ASTM F2299) | > 98% | 99.9% | > 98% | Evaluate non-viable particle filtration efficiency using monodispersed polystyrene latex spheres. |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | > 98% | 99.9% | > 98% | Determine filtration efficiency by comparing bacterial counts upstream and downstream of the test article. |
| Differential Pressure (Delta P) (EN 14683:2019) |
§ 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.