Search Results

The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons 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, provided non-sterile.

Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

The provided text does not describe an AI/ML device but rather a surgical mask (Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons). Therefore, the information requested for AI/ML devices, such as sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable and cannot be extracted.

However, I can provide the acceptance criteria and the reported device performance for the surgical masks based on the provided text, as these are relevant to non-AI/ML medical devices.

1. A table of acceptance criteria and the reported device performance (for the Surgical Mask):

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

The document mentions specific test standards for surgical masks. While it indicates that 32 test articles were used for the ASTM F1862 Fluid Resistance test, it does not explicitly state the sample sizes for the other tests, nor does it specify the data provenance (e.g., country of origin or whether the tests were retrospective or prospective). The tests are non-clinical, meaning they are performed on the device itself, not on human subjects.

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 information is not applicable as the device is a surgical mask and not an AI/ML device requiring expert interpretation for ground truth establishment. The testing involves standardized laboratory procedures.

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

This information is not applicable as the device is a surgical mask and not an AI/ML device requiring adjudication of human expert interpretations.

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

This information is not applicable as the device is a surgical mask and not an AI/ML device.

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

This information is not applicable as the device is a surgical mask and not an AI/ML device. The performance reported is that of the device itself under specified test conditions.

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

For the surgical mask, the "ground truth" is established by objective measurements and adherence to international and national standard test methods for material performance, such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, and flammability. These are laboratory-based, quantitative assessments, not subjective interpretations by experts or clinical outcomes data.

8. The sample size for the training set

This information is not applicable as the device is a surgical mask and not an AI/ML device that requires a training set.

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

This information is not applicable as the device is a surgical mask and not an AI/ML device that requires a training set and associated ground truth.

Ask a specific question about this device