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510(k) Data Aggregation
(90 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex, not made with natural rubber latex or fiberglass.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Iron core coated with PE.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study that proves the Surgical Face Mask meets those criteria.
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (ASTM F2100 Level 2) | Reported Device Performance (3 lots) | Result (Pass/Fail) |
|---|---|---|---|
| Fluid Resistance | 29 out of 32 pass at 120 mmHg (for level 3, which is a higher standard than requested Level 2) | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency | ≥ 98% | >98% | PASS |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | >99% | PASS |
| Differential Pressure | < 6.0 mmH2O/cm² | <3.2 mmH2O/cm² | PASS |
| Flammability | Class 1 | Class 1 | PASS |
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Non-irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance
The sample size for the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) consistently refers to "3 lots". The exact number of masks per lot tested is not specified in this document.
For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the document states "Under the conditions of the study, the subject device extract was determined to be..." which implies testing was performed, but the specific sample size is not mentioned.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it's a 510(k) submission for a Chinese manufacturer (Hubei Huanfu Plastic Products Co., Ltd) and tested against international and US standards (ISO, ASTM, EN, CFR), it's likely the testing was conducted in a laboratory setting to generate prospective data for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical face mask, and its acceptance criteria are based on objective, quantifiable performance standards (e.g., filtration efficiency, fluid resistance) measured in laboratory settings, not on subjective expert interpretation of medical images or conditions. Therefore, there are no "experts" establishing a ground truth in the context of clinical observations.
4. Adjudication method for the test set
Not applicable. As described above, the acceptance criteria are based on objective laboratory measurements against established standards, not on subjective assessments requiring 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 device is a surgical face mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (surgical face mask), not an algorithm or software.
7. The type of ground truth used
The ground truth for the performance of the surgical face mask is based on objective, standardized laboratory test results as defined by recognized international and national standards (e.g., ASTM F2100, ASTM F1862, EN 14683, ISO 10993, 16 CFR 1610). These standards define the acceptable performance thresholds for various parameters like filtration, fluid resistance, breathability, flammability, and biocompatibility.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, 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, this question is not relevant.
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