(197 days)
Medical surgical 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 matters. This device is single use and provided non-sterile.
The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.
The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.
Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.
The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥95% | Pass |
| Differential Pressure (mmH2O/cm²) (EN14683:2019 Annex C) | Determine breathability of the mask |
§ 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.