Search Results
Found 1 results
510(k) Data Aggregation
(198 days)
The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The Disposable medical mask is flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clip design for fitting the facemask around the nose. The Disposable medical mask is only one model: WSKZ-001 and the color is blue. The Disposable medical mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue, CAS number: 147-14-8), and the middle layer is made of melt blown fabric. Ear loops, which is held to cover the users' mouth and nose by two Ammonium nylon elastic bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the Disposable medical mask is in the middle layer of Disposable medical mask to allow the user to fit the Disposable mask around their noses, which is made of Polypropylene and metallic iron. The Disposable medical mask is sold non-sterile and is intended to be single use, and the intended environment is professional healthcare facility environment. The shelf life of each Disposable medical mask is 2 years. The dimensions of each Disposable medical mask are length 175mm and width 95mm. The dimension of nose clip is length 100mm, and the ear loop is length 170mm.
The provided text describes the acceptance criteria and performance data for a medical mask (K203388) seeking FDA clearance, primarily through comparison to a predicate device (K153409).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 98% | ≥99.2% (Passed 32/32) |
| Differential Pressure (Delta-P) | <5.0 mm H2O/cm² | <4.0 mm H2O/cm² (Passed 32/32) |
| Particulate Filtration Efficiency | ≥ 95% | ≥96.1% (Passed 32/32) |
| Resistance to penetration by synthetic blood | Fluid resistant claimed at 80 mmHg | 80 mmHg (Passed 32/32) |
| Flame Spread | Class 1 | ≥3 Seconds burn Time-Class 1 (Passed 32/32) |
| In vitro Cytotoxicity Test | Non-cytotoxic | Non-cytotoxic (Pass) |
| Skin Sensitization Test | Non-sensitizing | Non-sensitizing (Pass) |
| Skin Irritation Test | Non-irritating | 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 performance tests: 32 samples were used for each of the bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, and flame spread tests.
- Sample Size for biocompatibility tests: The document refers to "the subject device extract" for cytotoxicity, irritation, and sensitization tests, implying a sufficient sample was prepared according to the respective ISO standards. No specific number of devices or extracts is provided.
- Data Provenance: The document does not explicitly state the country of origin of the testing data or whether it was retrospective or prospective. However, the submitter, Everwin Toys (Dongguan)., Ltd., is located in China, and the application correspondent is in Guangzhou, China. The testing standards (ASTM, EN, ISO) are international.
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 device is a medical mask and the evaluation involves objective performance metrics (e.g., filtration efficiency, pressure, flammability) and biocompatibility, not diagnostic interpretation. Therefore, there are no "experts" in the sense of clinicians or radiologists establishing a "ground truth" for a test set. The ground truth is established by the results of standardized laboratory tests by qualified personnel following the specified ASTM, EN, and ISO methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation is based on objective laboratory measurements against predefined thresholds, not subjective interpretation requiring adjudication among experts.
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 medical mask, not an AI-powered diagnostic device. No human reader or AI assistance studies were performed or are relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical mask, not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance and biocompatibility tests is established by the results obtained from adherence to recognized international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These are objective, quantitative measurements and qualitative assessments (e.g., non-cytotoxic) conducted in a laboratory setting.
8. The sample size for the training set
Not applicable. This is a physical medical device (mask), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As
described above, this is a medical mask and does not involve AI algorithms or training sets.
Ask a specific question about this device
Page 1 of 1