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510(k) Data Aggregation
(161 days)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).
The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.
The mask is sold non-sterile and intended to be a single-use, disposable device.
The requested information pertains to a medical surgical mask, which is a physical device, not an AI/ML powered device. Therefore, acceptance criteria and study details relevant to AI/ML powered devices are not applicable.
However, based on the provided document, I can extract the acceptance criteria and performance data for the physical medical surgical mask for Level 1 and Level 3 performance, as well as biocompatibility testing.
Here's the relevant information about the acceptance criteria and the study that proves the device meets these criteria, focusing on the available context for a physical medical surgical mask:
1. A table of acceptance criteria and the reported device performance
Medical Surgical Mask (Level 1)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 95% | 32/32 Passed at ave. 99.3% |
| Differential Pressure (Delta-P) | < 5.0 mm H2O/cm² | 32/32 Passed at ave. 3.7 mm H2O/cm² |
| Particulate Filtration Efficiency | ≥ 95% | 32/32 Passed at ave. 98.12% |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 80 mmHg | 32/32 Passed at 80 mmHg |
| Flame Spread | Class 1 | 32/32 Passed ≥ 3 Seconds burn Time - Class 1 |
Medical Surgical Mask (Level 3)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 98% | 32/32 Passed at ≥ 99.8% |
| Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | 32/32 Passed at < 4.24 mm H2O/cm² |
| Particulate Filtration Efficiency | ≥ 98% | 32/32 Passed at ≥ 99.58% |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 160 mmHg | 32/32 Passed at 160 mmHg |
| Flame Spread | Class 1 | 32/32 Passed ≥ 3 Seconds burn Time - Class 1 |
Biocompatibility Testing
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In vitro Cytotoxicity Test | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: For the performance tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to penetration by synthetic blood, and Flame Spread), the reported sample size is 32/32 Passed, which implies 32 samples were tested for each performance criterion. The number of samples for biocompatibility tests is not explicitly stated but would typically involve biological samples.
- Data Provenance: Not explicitly stated in terms of country of origin. The submitter is "GUANGDONG KINGFA SCI.&TECH. CO., LTD." from China. The tests are non-clinical (laboratory-based) performance tests, not human data. The tests are prospective in nature, as they are performed on manufactured masks to ensure they meet standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable for this type of device. The "ground truth" for the performance tests is established by adhering to recognized international standards (e.g., ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610, and ISO 10993 series for biocompatibility). These standards define the test methodologies and pass criteria. The testing would be performed by qualified laboratory technicians in accordance with these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The tests performed are objective, quantitative laboratory tests with defined pass/fail criteria from international standards. There is no subjective interpretation requiring expert adjudication in the manner of medical image analysis.
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 a physical medical device (mask), not an AI/ML powered device, and therefore does not involve human readers interpreting output or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device without any algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by adherence to established international standards and their specified methodologies and acceptance limits. For example, the Bacterial Filtration Efficiency testing is conducted according to ASTM F2101-14, and biocompatibility according to ISO 10993-5 and ISO 10993-10.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model, so there is no "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, this question is irrelevant.
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