(119 days)
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is intended for single use by operating room personnel and other general healthcare workers and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Non Woven Face Mask is a single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are two options for the surgical mask to be secured on users via earloops or ties. Earloops are of urethane elastic fiber and not made with natural rubber latex; and ties are of spunbond polypropylene and also not made with natural rubber latex. The nose piece is a pliable white aluminum strip, covered by polypropylene covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices. Non Woven Face Mask has two models which are VQN0185W and VQN0185B. They are basically the same, the only difference is VQN0185W adopts earloops and VQN0185B adopts ties to secure the mask on user.
This is a 510(k) summary for a Non Woven Face Mask, indicating substantial equivalence to a predicate device. The information provided is for regulatory clearance of a medical device and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Predicate Device Performance | Subject Device Performance | Acceptance Criteria (Implied by Predicate) |
|---|---|---|---|
| Fluid Resistance | Fluid resistant | Pass at 120mm Hg | Fluid resistant (Pass at 120mm Hg) |
| Particle Filtration Efficiency (PFE) | Average 99.54% at 0.1 micron | Average 99.74% at 0.1 μm | ≥ 99.54% at 0.1 micron (or comparable) |
| Bacterial Filtration Efficiency (BFE) | >99.9% | Average 99.4% | >99.9% (or comparable) |
| Flammability Class | 1 | 1 | Class 1 |
| Delta – P (Breathability) | Average 3.38 mmH2O/cm² | Average 2.7 mmH2O/cm² | Lower Delta-P is preferable |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test. It only states that "The performance tests of Non Woven Face Mask were conducted." The data provenance is not specified beyond indicating it's for the "subject device" (V&Q Manufacturing Corporation, Wuhan, Hubei, CHINA). It's implied to be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device performance testing for a face mask, not an AI or image analysis device where expert ground truth is typically established. The performance tests are based on standardized methodologies (ASTM, ISO, MIL-M, CFR).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI or image analysis study requiring adjudication of expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The device itself (the face mask) is tested for its standalone physical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests are the established standards and methods outlined, such as ASTM F2299 for PFE, ASTM F1862 for fluid resistance, ASTM F 2101-14 for BFE, and ISO 10993 for biocompatibility. These are objective measurements against defined criteria, not expert consensus or pathology in the context of diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.