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510(k) Data Aggregation
(138 days)
The Procedure mask/Surgical 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, provided non-sterile.
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.
This document is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). The information provided demonstrates that the device meets the acceptance criteria through non-clinical testing.
Here's the breakdown of your requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Acceptance Criteria (Level 3 ASTM F2100-19) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Resistance to Penetration by Synthetic blood | No penetration at 160 mmHg | Pass at 160mmHg |
| Particulate Filtration Efficiency (PFE) | ≥98% | Blue mask: Pass at 99.75 % Black mask: Pass at 99.03 % |
| Bacterial Filtration Efficiency (BFE) | ≥98% | Blue mask: Pass at 99.87 % Black mask: Pass at 98.90 % |
| Differential Pressure | <6.0 mmH2O/cm² | Blue mask: Pass at 4.8 mmH2O/cm² Black mask: Pass at 3.7 mmH2O/cm² |
| Flammability | Class 1 | Class 1 |
| Cytotoxicity | Viability ≥70% of the blank | Viability ≥70% of the blank (Non-cytotoxic) |
| Sensitization | Non-sensitizing | Non-sensitizing |
| Irritation | Non-irritating | Non-irritating |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each non-clinical test. However, it indicates that the tests were performed in accordance with the referenced standards (e.g., ASTM F1862/F1862M, ASTM F2299/F2299M-03, ASTM F2101, EN 14683, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards typically define appropriate sample sizes for such tests.
The provenance of the data is that the tests were performed on the proposed device by Winner Medical Co., Ltd. The company is located in Shenzhen, Guangdong, China. The data is prospective, generated specifically for this 510(k) submission.
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 a non-clinical study for a physical device (surgical mask) based on standardized test methods for material performance and biocompatibility. Therefore, the "ground truth" is defined by the established acceptance criteria within those standards, as measured by laboratory testing. There are no "experts" in the sense of medical professionals establishing ground truth from observational data; rather, the expertise lies in the certified laboratories and personnel performing the standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical performance testing of a physical device. The results are obtained through standardized laboratory measurements.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (ASTM, EN, ISO, CFR) for medical face masks and biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set for this device.
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