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510(k) Data Aggregation
(416 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 single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. 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 piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study that proves the device (Disposable Medical Face Mask, K202676) meets these criteria. All information is extracted directly from the provided text.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance penetration synthetic blood (Test Method F1862) | To Determine synthetic blood penetration resistance | 29 Out of 32 pass at 120 mmHg | Lot 1: 31 out of 32 pass at 120mmHgLot 2: 31 out of 32 pass at 120mmHgLot 3: 32 pass at 120mmHgPass |
| Particulate Filtration Efficiency (ASTM F2299) | Determine particulate filtration efficiency | ≥ 98% | Lot 1: average 99.23%Lot 2: average 99.29%Lot 3: average 99.29%Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine the bacterial filtration efficiency | ≥ 98% | Lot 1: average 99.75%Lot 2: average 99.79%Lot 3: average 99.75%Pass |
| Differential Pressure (Delta - P) (EN 14683:2019, Annex C) | Determine breathing resistance or differential pressure | < 6.0 mmH₂0/cm² | Lot 1: average 4.07 mm H₂0/cm²Lot 2: average 4.07 mm H₂0/cm²Lot 3: average 4.13 mm H₂0/cm²Pass |
| Flammability (16 CFR 1610) | Determine flammability | Class 1 (Burn time ≥3.5 s, IBE, or DNI) | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Pass |
| Cytotoxicity (ISO 10993-5) | Determine the effects on cells | The test article should not have potential toxicity to L-929 in the MTT method. | Pass under the conditions of the study, the device is noncytotoxic. |
| Irritation (ISO 10993-10) | Estimate the potential for contact sensitization | The irritation response category in the rabbit should be negligible. | Pass under the conditions of the study, the device is nonirritating. |
| Sensitization (ISO 10993- 10) | Estimate the irritation potential of medical device | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass under the conditions of the study, the device is nonsensitizing. |
2. Sample size used for the test set and the data provenance
The sample size is specified for certain tests:
- Resistance penetration synthetic blood (ASTM F1862): 32 samples per lot (tested across 3 lots).
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the specific sample size per test is not explicitly stated, but results are provided for 3 lots.
- For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated beyond what is implied by the methodology (e.g., L-929 cells, rabbits, guinea pigs).
The data provenance is not explicitly stated in terms of country of origin for the testing, nor whether it was retrospective or prospective. However, the manufacturer is from China (Zhejiang Senhong Medical&Instrument Co., Ltd.) and the submission was made to the US FDA. The studies appear to be laboratory-based non-clinical performance tests.
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 and not provided. The ground truth for these tests is established by standardized test methodologies and their respective measurement criteria, not by expert consensus or interpretations. For example, for "Resistance penetration synthetic blood," the ground truth is simply whether the specific number of samples passed the physical penetration test at a certain pressure.
4. Adjudication method for the test set
Not applicable. The tests are standardized physical and biological performance assessments, 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
Not applicable. This device is a disposable medical face mask, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests are for the physical and biological performance of the mask itself.
7. The type of ground truth used
The ground truth for the device's performance is based on established industry standards and regulatory requirements for medical face masks. This includes:
- Physical properties (e.g., filtration efficiency, differential pressure, flammability) measured against quantitative thresholds.
- Biocompatibility properties (e.g., cytotoxicity, irritation, sensitization) measured against predefined biological responses.
The "ground truth" is determined by the results of these standardized laboratory tests meeting the pre-defined acceptance criteria.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this device.
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