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The Bawmed UK Bawmed EZ-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.

Bawmed Rescue Mask (also referred to as Bawmed EZ-Mask)

This document is a 510(k) clearance letter from the FDA for a medical device called the "Bawmed Rescue Mask" (later referred to as "Bawmed EZ-Mask"). It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics. It's a regulatory clearance letter, not a scientific study report.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted, and what cannot:

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

• Cannot be provided. This document does not specify acceptance criteria or report device performance in terms of quantifiable metrics. It's a clearance letter based on substantial equivalence.

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

• Cannot be provided. The document does not describe any specific testing or the sample size used.

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)

• Cannot be provided. This information is not present.

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

• Cannot be provided. This information is not present.

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

• Cannot be provided. This document does not describe an MRMC study or any AI component. The device is a physical resuscitator mask.

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

• Cannot be provided. This is not relevant as the device is not an algorithm.

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

• Cannot be provided. This information is not present.

8. The sample size for the training set

• Cannot be provided. This information is not present.

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

• Cannot be provided. This information is not present.

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