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510(k) Data Aggregation
(63 days)
The Disposable 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 is a single use, disposable device(s), provided non-sterile.
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance metrics, multi-reader multi-case studies, effect size of human readers improving with AI, standalone algorithm performance, and ground truth establishment/training sets, are not applicable.
However, I can extract the acceptance criteria and reported device performance for this medical face mask from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Discussion |
|---|---|---|---|
| Particulate Filtration Efficiency | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.68%, Lot 2: 99.56%, Lot 3: 99.81% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.926%, Lot 2: 99.93%, Lot 3: 99.936% | Similar (Subject device performance meets or exceeds predicate) |
| Bacterial Filtration Efficiency (BFE) | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.9%, Lot 2: 99.9%, Lot 3: 99.9% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: ≥99%, Lot 2: ≥99%, Lot 3: ≥99% | Similar (Subject device performance meets criteria, although specific values for predicate are higher than the "≥99%" reported for the subject) |
| Differential Pressure | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 3.8 mm H2O/cm², Lot 2: 3.6 mm H2O/cm², Lot 3: 3.7 mm H2O/cm² | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: <5 mm H2O/cm², Lot 2: <5 mm H2O/cm², Lot 3: <5 mm H2O/cm². (Note: Specific values are also provided: Lot 1: 3.9 mm H2O/cm², Lot 2: 4.1 mm H2O/cm², Lot 3: 4.2 mm H2O/cm² based on the raw data in the table, but the general criterion is <5 mm H2O/cm²) | Similar (Subject device performance meets the <5 mm H2O/cm² criterion) |
| Flammability | Class 1, 3 non-consecutive lots tested, using a sample size of 32/lot. | Class 1, 3 non-consecutive lots tested, using a sample size of 32/lot. | Identical |
| Fluid Resistance | 32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots tested. | Pass at 120 mmHg | Similar (Implies similar passing rate based on the "pass" result, though specific sample size/pass numbers from the subject device are not explicitly listed in the comparison table, only for the predicate.) |
| Biocompatibility | ISO 10993-5 and ISO10993-10; device extract non-cytotoxic, non-sensitizing, and non-irritating | ISO 10993-5 and ISO10993-10; device extract non-cytotoxic, non-sensitizing, and non-irritating | Identical |
2. Sample size used for the test set and the data provenance:
- For Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: 3 non-consecutive lots were tested, with a sample size of 32 per lot.
- For Fluid Resistance: The predicate device had 32 out of 32 per lot passing. The subject device simply states "pass at 120 mmHg," implying similar testing was conducted.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were non-clinical, conducted by Hubei Mediunion Medical Products Co., Ltd. for their proposed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are objective physical and biological performance tests for a medical face mask, not expert-adjudicated diagnoses or interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. These are objective physical and biological performance tests.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Test Standards: The "ground truth" or acceptance criteria are based on established international and national standards for medical face mask performance, such as ASTM F1862, ASTM F2101, ASTM F2100, EN 14683, ISO 10993-5, ISO 10993-10, and 16 CFR Part 1610. The device's performance is measured directly against these standard specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device; there is no "training set."
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