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510(k) Data Aggregation
(265 days)
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is 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 of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.
The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. These masks are single use, disposable devices, provided non-sterile.
This information describes the performance testing for a medical device (a surgical mask), not an AI/ML device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.
Here's the breakdown of the provided information:
1. A table of acceptance criteria and the reported device performance
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM F2100 Level 1 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥95% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥95% | Pass |
| Differential Pressure | EN 14683 | <5.0 mmH2O/cm² | Pass |
| Fluid Resistance | ASTM F1862 | 80 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Face Mask Performance | EN 14683 | EN 14683 Type II | Pass |
| Bacterial Filtration Efficiency | EN 14683 | ≥98% | Pass |
| Differential Pressure | EN 14683 | <40 Pa/cm² | Pass |
| Microbial Cleanliness | ISO 11737-1 | ≤30 cfu/g | Pass |
| Biocompatibility | ISO 10993 | Pass | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Non-irritant | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each test. The tests are non-clinical performance tests on the physical mask, not data-driven tests.
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. These are physical performance tests that follow standardized test methods, not expert-adjudicated ground truth for AI/ML performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication of results.
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 a surgical mask, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is defined by the specific, recognized international and national standards (ASTM, EN, ISO, 16 CFR Part 1610) that outline the methodologies and acceptance criteria for evaluating the physical and biological properties of surgical masks.
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. There is no training set for this type of device.
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