(198 days)
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
The provided document is a 510(k) Premarket Notification for a Medical Mask (Model: KKF-1A). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than an AI-powered medical device.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for AI test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a traditional medical device (a mask) and standard testing for physical properties and biological safety.
However, I can extract the acceptance criteria and performance data for the medical mask based on the provided tables.
Acceptance Criteria and Reported Device Performance for the Medical Mask (Model: KKF-1A)
| Item (Performance Test) | Acceptance Criteria for Level 1 (ASTM F2100-19) | Reported Device Performance (Test Results) |
|---|---|---|
| Fluid Resistance Performance (mmHg) ASTM F1862 | 29 out of 32 pass at 80 mmHg | Passed at 80 mmHg |
| Particulate Filtration Efficiency Performance (%) ASTM F2299 | ≥ 95% | Passed at 99.3% |
| Bacterial Filtration Efficiency Performance (%) ASTM F2101 | ≥ 95% | Passed at 98.1% |
| Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C |
§ 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.