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510(k) Data Aggregation
(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 | <6.0 mmH2O/cm² | Pass (<6.0 mmH2O/cm²) |
| Flammability (16 CFR Part 1610) | Determine flammability flame or spread | Class 1 | Pass (Class 1) |
Biocompatibility Testing:
| Item | Acceptance Criteria (Implied) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | Noncytotoxic | Pass (device is noncytotoxic) |
| Sensitization | Non-sensitizing | Pass (device is non sensitizing) |
| Irritation | Non-irritating | Pass (device is nonirritating) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For Fluid Resistance: 32 samples (implied from "≥29 of 32 pass").
- For other tests (Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The specific sample size for each test is not explicitly stated, but these are typically standardized per test method (e.g., ASTM F2299, ASTM F2101).
- Data Provenance: Not specified, but generally, these are lab-based, non-clinical tests performed by the manufacturer or a contracted lab. The submitter is R&R Medical Corporation Ltd. from Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes performance testing of a physical medical device (surgical face mask) rather than an AI/ML diagnostic or assistive device that requires expert-established ground truth. The "ground truth" for these tests are the objective measurements against established international standards (ASTM, EN, CFR).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, this is for a physical device, not an AI output requiring human adjudication.
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. No MRMC study was conducted as this is not an AI-assisted device for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no standalone algorithm or AI component discussed in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Test Standards: The "ground truth" for this device's performance is based on established international and national standards for surgical masks. These standards define the methodology and criteria for evaluating properties like fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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