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510(k) Data Aggregation
(92 days)
The Disposable Surgical Masks 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) are 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 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex and polyester fiber. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The document describes the acceptance criteria and performance of the Disposable Surgical Mask device by Safeway Industry Healthcare.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Acceptance Criteria (Level 2) | Acceptance Criteria (Level 3) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 120 mmHg | 29 out of 32 Pass at 160 mmHg | 32 out of 32 Pass at 120 mmHg; 32 out of 32 Pass at 160 mmHg; 3 non-consecutive lots (Lot1, Lot2, Lot3) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | ≥ 98% | Lot1: 99.1%; Lot2: 98.4%; Lot3: 98.7% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | ≥ 98% | Lot1: 99.9%; Lot2: 99.8%; Lot3: 99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0mmH2O/cm² | < 6.0mmH2O/cm² | Lot1: 4.43mmH2O/cm²; Lot2: 4.68mmH2O/cm²; Lot3: 4.35mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Lot1: Class 1; Lot2: Class 1; Lot3: Class 1 | PASS |
| Cytotoxicity | Non-Cytotoxic | N/A (implied) | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Non-Irritating | N/A (implied) | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Non-Sensitizing | N/A (implied) | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862): 32 samples per test condition for each of the 3 non-consecutive lots (96 samples total for this test). The data provenance is not explicitly stated as country of origin, but the submission is from Safeway Industry Healthcare in Hubei, China, implying the tests were conducted there or commissioned by them. The study is retrospective as these are test results from manufactured lots.
- Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta P) (EN 14683 Annex C), Flammability (16 CFR 1610): The results are reported for 3 non-consecutive lots (Lot1, Lot2, Lot3). The specific number of masks tested within each lot for these performance characteristics is not explicitly stated, but the results are given as a single value per lot for efficiency/pressure. The data provenance is implied to be from China and the studies are retrospective.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): The sample size for these tests is not explicitly stated but "the device" is referenced, meaning the materials of the device were tested. The data provenance is implied to be from China and the studies are retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable (N/A) because the device is a Disposable Surgical Mask, and its performance is evaluated through standardized laboratory-based material science tests (e.g., filtration efficiency, fluid resistance) and biocompatibility tests. There is no human interpretative "ground truth" established by experts in the context of this device's performance evaluation.
4. Adjudication method for the test set:
This information is N/A for the same reasons as #3. The tests are objective quantitative measurements, not subjective evaluations 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:
This information is N/A. The device is a surgical mask, not an AI software or system designed for interpretation by human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is N/A. The device is a physical product (surgical mask), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of the surgical mask is based on objective, standardized laboratory test results against predefined regulatory and industry standards (e.g., ASTM F2100, ASTM F1862, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this type of device.
8. The sample size for the training set:
This information is N/A. The device described is a physical product (surgical mask), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is N/A for the same reason as #8.
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