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510(k) Data Aggregation
(201 days)
The 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven 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 not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and study results for the Allmed Medical Products Co., Ltd. Surgical Mask.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 1 unless otherwise specified) | Reported Device Performance | Result (compared to criteria) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 80 mmHg | 32 out of 32 pass at 80 mmHg, 3 lots | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | Pass at 99.85%, 99.90%, 99.75% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | Pass at 99.9%, 99.9%, 99.9% | Pass |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 5.0mmH2O/cm² | Pass at 4.6mmH2O/cm², 4.5mmH2O/cm², 4.6mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Device is non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Irritation (ISO 10993-10) | Device is non-irritating | Under the conditions of the study, the device is non-irritating. | Pass |
| Sensitization (ISO 10993-10) | Device is 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:
- Fluid Resistance (ASTM F1862): 3 lots were tested, and a total of 32 samples per lot were assessed (implied by "32 out of 32 pass"). The provenance of this data is not specified (e.g., country of origin, retrospective/prospective).
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample sizes used for these tests. The provenance of this data is not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests performed are non-clinical, laboratory-based performance tests for a surgical mask, not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set:
- Not applicable. The tests performed are objective, quantitative laboratory measurements, not subjective human-interpreted data 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 is a non-clinical device (surgical mask), and no AI assistance or human reader studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a non-clinical device (surgical mask), and no algorithm performance was assessed.
7. The type of ground truth used:
- For the non-clinical performance tests (Fluid Resistance, Filtration Efficiencies, Differential Pressure, Flammability), the "ground truth" is established by industry standards and regulatory requirements (e.g., ASTM, EN, CFR standards). The device's performance is measured against the specifications outlined in these standards.
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the "ground truth" is established by a scientifically validated methodology (ISO 10993 standards) to determine the biological response of the device material.
8. The sample size for the training set:
- Not applicable. This is a non-clinical device (surgical mask) and does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as point 8.
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