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510(k) Data Aggregation
(92 days)
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile.
Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow the users to adjust the nose piece according to the shape of the bridge of the nose.
The provided text describes the acceptance criteria and the study results for a medical surgical mask (Model: ZKM-U01). It does not pertain to an AI/ML powered device, therefore, information such as human-in-the-loop performance, effect size of AI assistance, and details about training/test set provenance are not applicable.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg | Yes |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥98% | Pass, average 99.99% | Yes |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | Pass, average > 99.8% | Yes |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | <6.0 mmH2O/cm² | Pass, average 5.5 mmH2O/cm² | Yes |
| Flammability (16 CFR 1610) | Class 1 | Pass, Class I | Yes |
| In vitro cytotoxicity (ISO 10993-5) | The test article should not have potential toxicity to L-929 in the MTT method. | Pass, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method. | Yes |
| Skin sensitization (ISO 10993-10) | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of delayed dermal contact sensitization in the guinea pig. The test article Surgical face mask has no potential skin sensitization on guinea pigs in the extraction method. | Yes |
| Skin irritation (ISO 10993-10) | The irritation response category in the rabbit should be negligible. | Pass, the response of the test article extract was categorized as negligible under the test condition. The test article Surgical Face Mask has no potential skin irritation on rabbit in the extraction method. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each performance test (e.g., number of masks tested for fluid resistance). The studies were non-clinical, meaning they were conducted in a laboratory setting rather than with human patients. Data provenance is not described beyond the tests being conducted on the "Medical Surgical Mask (Model: ZKM-U01)".
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as this is a non-clinical performance study of a physical device, not an AI/ML device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
Not applicable for a non-clinical performance study of a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-powered diagnostic device so no MRMC study was performed.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The ground truth for the performance tests was established by objective measurements based on internationally recognized standards and methodologies (e.g., ASTM, ISO, EN, CFR standards). For example:
- Fluid Resistance: Visual observation of penetration at a specific pressure.
- Filtration Efficiency: Measurement of particle/bacterial count before and after filtration.
- Differential Pressure: Direct measurement of pressure difference across the mask.
- Flammability: Observation of burn characteristics.
- Biocompatibility: In-vitro cell culture and in-vivo animal (guinea pig, rabbit) responses to extracts as per ISO standards.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
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