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510(k) Data Aggregation
(164 days)
The surgical masks are 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(s), provided non-sterile.
The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
The provided document is a 510(k) Premarket Notification for the ECOMA Level 2 Disposable Surgical Mask with Ear Loops. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study of the device itself. Therefore, many of the requested categories regarding human expert studies, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this type of regulatory submission for this medical device.
Here's the information extracted from the document regarding acceptance criteria and performance, as applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | ≥ 98% Average BFE for all samples tested | 96/96 samples passed ≥ 98% Average BFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| ASTM F2299-Particulate Filtration Efficiency (PFE) | ≥ 98% Average PFE for all samples tested | 96/96 samples passed ≥ 98% Average PFE (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| Differential Pressure | Samples must be < 6.0 mm H2O/cm² | 96/96 samples passed differential pressure < 6.0 mm H2O/cm² (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| ASTM F1862-Fluid Resistance | At least 29 out of 32 specimens per lot show passing results at 120 mmHg | 95/96 samples passed fluid resistance at 120 mmHg (3 lots, 32 samples per lot with a lot size of 200,000 each) |
| 16 CFR 1610-Flammability | All samples must be Class I | 96/96 samples passed Class I flammability test (96/96 samples passed Class I flammability test) |
| Sensitization | The sample is non-sensitizing. | The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not cause significant irritation or sensitization reaction to the test animals.) |
| Irritation | The sample is non-irritating. | The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not cause significant irritation or sensitization reaction to the test animals.) |
| Cytotoxicity | The sample is non-cytotoxic. | The device was tested in accordance with ISO 10993 and passed acceptance criteria. (Under the testing conditions, the subject surgical mask did not show potential cytotoxicity.) |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests: For ASTM F2101 (BFE), ASTM F2299 (PFE), Differential Pressure, and 16 CFR 1610 (Flammability), the sample size was 96 individual samples, divided into 3 lots of 32 samples each.
- Sample Size for Fluid Resistance: 96 individual samples, divided into 3 lots of 32 samples each. The acceptance criteria required at least 29 out of 32 specimens per lot to pass.
- Sample Size for Biocompatibility (Sensitization, Irritation, Cytotoxicity): While a specific number of samples isn't given for these tests, the document states "The device was tested in accordance with ISO 10993 and passed acceptance criteria," and specifies results from "test animals" for sensitization and irritation. ISO 10993 standards typically define the appropriate sample sizes and methodologies for biological evaluation tests.
- Data Provenance: The tests were non-clinical (laboratory-based) and conducted to evaluate the physical and biological characteristics of the mask according to recognized standards (ASTM, 16 CFR, ISO). The manufacturing location is Xianning, Hubei, China (XIANNING ECO MEDICAL ARTICLES CO., LTD.), so it can be inferred the samples originated from the manufacturer. The data is based on controlled laboratory testing, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are non-clinical (laboratory-based) performance tests against established technical standards (e.g., ASTM, ISO), not studies requiring human expert adjudication or ground truth establishment based on human interpretation.
4. Adjudication method for the test set
Not applicable. These are non-clinical (laboratory-based) performance tests against established technical standards, not studies requiring human adjudication.
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 510(k) submission for a surgical mask, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for a surgical mask, not an AI-powered diagnostic device.
7. The type of ground truth used
The "ground truth" used for these tests are the established performance specifications derived from recognized industry standards like ASTM F2101, ASTM F2299, Differential Pressure (EN 14683), ASTM F1862, 16 CFR 1610, and biocompatibility standards (e.g., ISO 10993). The device's performance is measured against these numerical and qualitative benchmarks.
8. The sample size for the training set
Not applicable. This is a 510(k) submission for a non-AI medical device (surgical mask). There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is a 510(k) submission for a non-AI medical device.
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