Search Results

The Umbilical Cord Clamp is indicated for use following a live birth. It provides a means of constricting the umbilical cord in order to prevent loss of blood as the cord dries and shrinks after birth. It is used immediately following delivery of the infant and prior to the separation of umbilical cord between mother and infant.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI or diagnostic device against specific acceptance criteria.

Therefore, almost all of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not present in this document.

Here's what can be inferred or directly stated from the provided text, and what cannot:

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

• Not present. This document does not establish specific performance criteria like sensitivity, specificity, or accuracy. It's a regulatory clearance based on substantial equivalence.

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

• Not present. There is no mention of a test set, sample size, or data provenance as this is not a performance study as typically understood for AI/diagnostic devices.

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):

• Not present. No experts are mentioned in the context of establishing ground truth for a test set. The clearance is based on comparison to a predicate device.

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

• Not present. No test set or adjudication method is described.

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/Not present. This is a physical medical device (umbilical cord clamp), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not included.

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

• Not applicable/Not present. As above, this is not an algorithm or AI device.

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

• Not present in the context of a performance study. The "ground truth" for this regulatory approval is the legally marketed predicate device to which the new device is compared for "substantial equivalence."

8. The sample size for the training set:

• Not applicable/Not present. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable/Not present. No training set ground truth to establish.

In summary, the provided document (an FDA 510(k) clearance letter) is about regulatory approval for a physical medical device (Umbilical Cord Clamp) based on substantial equivalence. It does not contain information about the performance evaluation of an AI or diagnostic device against specific acceptance criteria. Therefore, most of the requested details are not applicable or not present in this type of document.

Ask a specific question about this device