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510(k) Data Aggregation
(57 days)
The Medical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device 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 model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Average Result) | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 120 mmHg for Level 2 | Level 2: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested) | PASS |
| (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | Level 3: 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested) | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Level 2: 99.2% (3 non-consecutive lots tested) | PASS |
| (ASTM F2299) | Level 3: 99.5% (3 non-consecutive lots tested) | PASS | |
| Bacterial Filtration Efficiency | ≥ 98% | Level 2: 99.3% (3 non-consecutive lots tested) | PASS |
| (ASTM F2101) | Level 3: 99.3% (3 non-consecutive lots tested) | PASS | |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Level 2: 5.0 mmH2O/cm² (3 non-consecutive lots tested) | PASS |
| (EN 14683 Annex C) | Level 3: 4.4 mmH2O/cm² (3 non-consecutive lots tested) | PASS | |
| Flammability | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested) | PASS |
| (16 CFR 1610) | Level 3: Class 1 (3 non-consecutive lots tested) | PASS | |
| Biocompatibility - Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Non-Sensitizing | PASS: 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 Performance (ASTM F1862): 32 samples per lot, tested across 3 non-consecutive lots.
- Particulate Filtration Efficiency (ASTM F2299): 32 samples per lot, tested across 3 non-consecutive lots.
- Bacterial Filtration Efficiency (ASTM F2101): 32 samples per lot, tested across 3 non-consecutive lots.
- Differential Pressure (EN 14683 Annex C): 32 samples per lot, tested across 3 non-consecutive lots.
- Flammability (16 CFR 1610): 32 samples per lot, tested across 3 non-consecutive lots.
- Biocompatibility (ISO 10993-5, ISO 10993-10): The document does not specify the exact sample size for biocompatibility testing, but it was conducted on the mask materials (nose clip and ear loops components were specifically mentioned).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they were "non-clinical tests conducted to verify that the proposed device met all design specifications."
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. The tests performed are objective performance tests on the medical device itself (face mask), not assessments requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are objective laboratory performance tests with defined pass/fail criteria, not 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:
- No MRMC comparative effectiveness study was done. This medical device is a face mask, and the submission focuses on its physical and biological performance characteristics, not an AI-assisted diagnostic or interpretive tool.
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 medical face mask, not an algorithm or software. All performance tests are on the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established scientific and regulatory standards (e.g., ASTM F2100-19, EN 14683, ISO 10993). Compliance is determined by objective measurements against these standards.
8. The sample size for the training set:
- This information is not applicable. This is a medical face mask, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons mentioned above.
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