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510(k) Data Aggregation
(294 days)
The FLUIDSHIELD* 1 Procedure Mask(s) 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 intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.
The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.
The provided document is a 510(k) summary for a medical device (face masks) and describes non-clinical performance testing against established standards, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2101 (Bacterial Filtration Efficiency) | To demonstrate adequate bacterial filtration efficiency | Under the conditions of the study, at least 95% efficiency | Pass (≥ 95%) |
| EN 14683:2019+AC Annex C (Breathability) | To demonstrate acceptable breathability | Under the conditions of the study, at most 5.0 mm H2O/cm² | Pass (< 5.0 mmH2O/cm²) |
| ASTM F2299 (Particulate Filtration Efficiency) | To demonstrate adequate particulate filtration efficiency | Under the conditions of the study, at least 95% efficiency | Pass (≥ 95%) |
| ASTM F1862 (Fluid Resistance) | To demonstrate adequate resistance to liquids | Under the conditions of the study, passing at 80 mmHg conditions | Pass (80 mmHg) |
| 16 CFR 1610 (Flame Resistance) | To evaluate flame spread resistance | Class 1 under the conditions of the testing | Pass (Class 1) |
| ASTM F2100-19 (Mask Performance Level) | To evaluate mask performance | Level 1 under the conditions of the evaluation | Pass (Level 1) |
| EN ISO 11737-1 Bioburden (Microbial Cleanliness) | To evaluate microbial cleanliness | Under the conditions of the study, at most 30 CFU/g | Pass (< 30 CFU/g) |
| ISO 10993-5 (Cytotoxicity) | To evaluate the cytotoxic potential of the mask | Under the conditions of the study, non-cytotoxic | Pass (non-cytotoxic) |
| ISO 10993-10 Sensitization | To evaluate the sensitization potential of the mask | Under the conditions of the study, not a sensitizer | Pass (not a sensitizer) |
| ISO 10993-10 Irritation | To evaluate the irritation potential of the mask | Under the conditions of the study, not an irritant | Pass (not an irritant) |
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 exact sample sizes used for each test. The tests are non-clinical (e.g., material testing, not patient data). The provenance is not explicitly stated beyond being conducted for a US FDA 510(k) 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. These are non-clinical performance tests against established standards (ASTM, ISO, EN), not diagnostic studies requiring expert human review to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or subjective interpretations that would require 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. This is not an AI-assisted diagnostic device; it is a physical medical device (face mask).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the specific performance and safety standards (e.g., ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility). The device's performance is compared directly against the quantitative or qualitative criteria set by these standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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