(541 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks 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 non-sterile.
The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
The provided document is a 510(k) summary for a Surgical Face Mask and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information related to an AI/ML powered device, comparative effectiveness studies (MRMC), or clinical studies with human readers. Therefore, several requested sections, such as those pertaining to AI/ML, human expert involvement, and ground truth establishment from clinical data, are not applicable based on the provided text.
Here’s an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Surgical Face Mask, and the performance is evaluated based on ASTM and EN standards relevant to such masks. There are three levels of surgical face masks (Level 1, Level 2, and Level 3), each with specific acceptance criteria. The test results consistently show that the device "PASS"es all specified criteria.
Level 1 Surgical Face Mask (Model: SQ-1001)
| Item | Acceptance Criteria (Level 1) | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 80 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | PASS |
| Differential Pressure (EN 14683 Annex C) |
§ 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.