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The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

ASEPT® Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. The ASEPT® Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

The document describes the acceptance criteria and performance of the ASEPT® Surgical Face Mask.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Fluid Resistance Performance: At least 32 specimens were used for testing (acceptance criteria states "29 out of 32 specimens").
• For Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, Cytotoxicity, Irritation, and Sensitization, the document states "All samples met the predetermined acceptance criteria," implying that a sample set was tested for each, but the exact number of samples for these tests is not explicitly stated.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 (surgical face mask) is evaluated based on non-clinical performance standards and biocompatibility tests, not clinical evaluations requiring expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a diagnostic context does not apply here. The results are from standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the evaluation is based on objective laboratory testing against pre-defined standards, not on subjective expert consensus or 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 medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing, not a diagnostic AI device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by the specified standards and acceptance criteria for each performance characteristic (e.g., ASTM F1862 for fluid resistance, ASTM F2100-19 for filtration efficiency, ISO 10993 for biocompatibility). The device's performance is measured directly against these objective benchmarks in a laboratory setting.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not a machine learning model.

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