(264 days)
The LAITEST MEDICAL FACE MASK 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
The provided document is a 510(k) Premarket Notification for a surgical face mask (LAITEST Surgical Face Mask, K214035). This type of document focuses on demonstrating substantial equivalence to a previously cleared device, primarily through bench testing for safety and performance, rather than a clinical study involving human patients or complex AI algorithms.
Therefore, the requested information (sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, detailed ground truth establishment for AI, etc.) is not applicable to this submission, as it does not describe an AI medical device or a clinical study in the typical sense.
However, I can extract the acceptance criteria and performance data for the device based on the non-clinical (bench) tests performed.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Determine synthetic blood penetration resistance | ≥29 of 32 pass at 120 mmHg | Pass (≥29 of 32 pass at 120 mmHg) |
| Particulate Filtration Efficiency (ASTM F2299) | Determine the bacterial filtration efficiency | > 98% | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | > 98% | Pass (≥ 98%) |
| Differential Pressure (Delta P) (EN 14683) | Determine breathing resistance or differential pressure |
§ 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.