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510(k) Data Aggregation
(188 days)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
The provided text describes a 510(k) submission for a Surgical Face Mask and outlines the performance criteria and testing conducted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML product, so the questions regarding AI/ML-specific criteria (like effect size of AI assistance, AI-only performance, training set details) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance ASTM F1862-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | No penetration pass at 160mmHg | Pass, no penetration pass at 160mmHg. |
| Particulate Filtration Efficiency ASTM F2299-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.56% |
| Bacterial Filtration Efficiency ASTM F2101-19 | To evaluate the bacterial filtration efficiency (BFE) of mask. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.9% |
| Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-19 | To measure the differential pressure of mask which is related to breathability. | <6.0 mmH2O/cm2 | Pass, CM2006 and CM2008: Average 3.69 mmH2O/cm2; A88: Average 3.55 mmH2O/cm2 |
| Flammability 16 CFR 1610 | To evaluate the flammability of mask. | Class 1 | Pass, Class 1 |
| In vitro cytotoxicity ISO 10993-5 | To evaluate the biological safety of the product which has direct contact with intact skin. | 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. |
| Skin sensitization ISO 10993-10 | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of causing 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. |
| Skin irritation ISO 10993-10 | To evaluate the biological safety of the product which has direct contact with intact skin. | 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. |
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 sample sizes used for each performance test. The tests are general medical device performance and biocompatibility studies, not clinical trials with human participant data. The provenance for these tests would typically be laboratory testing conducted by the manufacturer or a contracted lab. The manufacturer is based in Shenzhen, China.
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)
Not applicable. These are physical and biological performance tests, not studies requiring expert interpretation of results in the way an AI/ML diagnostic device would. The "ground truth" for these tests comes from standardized testing methodologies outlined in the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for standardized physical and biological performance testing.
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 surgical face mask, not an AI/ML-powered diagnostic tool, so MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests comes from the established parameters and measurement techniques defined within the cited international standards (e.g., ASTM F1862-17 for fluid resistance, ASTM F2299-17 for particulate filtration, ISO 10993-5 for cytotoxicity). These are objective measurements rather than subjective interpretations or clinical outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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