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Beraclamp™, Model BC-1, Umbilical Cord Cutting and Clamping Device

This document appears to be a 510(k) clearance letter from the FDA for a medical device called "Beraclamp™, Model BC-1, Umbilical Cord Cutting and Clamping Device." It's a regulatory document indicating that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, this document does not contain the information required to answer your request.

The FDA 510(k) clearance process is for demonstrating substantial equivalence to a predicate device, not necessarily for proving the device meets acceptance criteria through a detailed study as you've outlined. While there are performance data, safety, and effectiveness discussions in a 510(k) submission, the provided letter is the outcome of that review, not the detailed study report itself.

To answer your questions, I would need access to the full 510(k) submission document, which would contain information on the studies conducted to support the substantial equivalence claim.

Specifically, this document does not contain information on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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