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510(k) Data Aggregation
(109 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided FDA 510(k) summary describes the acceptance criteria and the study results for the Disposable Surgical Face Mask (M663BE, M663BT).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To demonstrate resistance to penetration by synthetic blood. | ASTM F2100 Level 3 29 out of 32 pass at 160 mmHg for Level 3 | Pass 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass Average 99.929%, 99.947%, 99.978% |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Pass Average 99.8%, 99.9%, 99.8% |
| Differential Pressure (EN 14683 Annex C) | To demonstrate the functionality of the subject device. | < 6.0 mmH2O/cm² | Pass Average 3.7 mmH2O/cm², 3.8 mmH2O/cm², 3.8 mmH2O/cm² |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | Pass, Class 1 |
| Cytotoxicity (ISO 10993-5) | To demonstrate the safety of the subject device. | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | To demonstrate the safety of the subject device. | Non-irritating | Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | To demonstrate the safety of the subject device. | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample size used for the test set and the data provenance
- Fluid Resistance Test:
- Sample size: 32 samples per lot, tested across 3 lots. (Total 96 masks).
- Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility (Cytotoxicity, Irritation, Sensitization):
- The specific number of samples for each of these tests is not individually detailed in the provided summary, beyond the "3 lots" mention for fluid resistance which might imply similar lot-based testing for other performance characteristics. The results are typically reported as averages across tests.
- Data Provenance: Not explicitly stated, implied to be laboratory testing of manufactured masks.
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 as the device is a Disposable Surgical Face Mask, and the performance evaluation relies on standardized non-clinical laboratory tests rather than expert interpretation of medical images or patient data.
4. Adjudication method for the test set
This information is not applicable as the performance evaluation relies on standardized non-clinical laboratory tests with objective pass/fail criteria, not on human interpretation or adjudication processes.
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 not applicable. The device is a surgical face mask, and the evaluation does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical face mask, and its performance evaluation does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by reference to established industrial standards and test methods. For example:
- Fluid Resistance: ASTM F1862 and ASTM F2100 Level 3.
- Particulate Filtration Efficiency: ASTM F2299.
- Bacterial Filtration Efficiency: ASTM F2101.
- Differential Pressure: EN 14683 Annex C.
- Flammability: 16 CFR 1610.
- Biocompatibility: ISO 10993 (Parts 5 and 10).
8. The sample size for the training set
This information is not applicable. The device is a surgical face mask and its development and evaluation do not involve machine learning models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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