(56 days)
The Surgical 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 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(s), provided non-sterile.
The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the face mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.
The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The document is a 510(k) premarket notification for a Surgical Face Mask. It primarily focuses on the device's substantial equivalence to a predicate device, supported by non-clinical performance testing and biocompatibility assessments. It explicitly states that no clinical studies were performed. As such, the information provided does not pertain to the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human-in-the-loop diagnostic device as implied by the detailed questions.
Therefore, many of the requested details, such as those related to AI performance, human reader improvement, ground truth establishment for training and test sets, expert consensus, and multi-reader multi-case studies, are not applicable to this document.
However, I can extract the acceptance criteria and the device performance for the non-clinical tests conducted for this surgical face mask.
Here's the information based on the provided document, addressing the extractable points and noting the non-applicability of others:
Device: Surgical Face Mask (Kingstar Medical (Xianning) Co., Ltd.)
Predicate Device: K210433 Surgical Face Mask (Wuhan Dymex Healthcare Co., Ltd.)
1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)
| Test Methodology | Purpose | Acceptance Criteria: ASTM F2100 Level 3 | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 pass at 160 mmHg for level 3 | Pass (32 out of 32 pass at 160 mmHg, 3 lots) |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass (minimum 99.21%) |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass (99.9%) |
| Differential Pressure (EN 14683 Annex C) | To demonstrate the functionality of the subject device. |
§ 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.