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Sterile, single-use, disposable umbilical cord clamp, used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth, prior to and after cutting.

Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).

This document describes a 510(k) premarket notification for an Umbilical Cord Clamp. It does not contain information about acceptance criteria or a study proving device performance in the way a medical AI/ML device submission would. The document focuses on establishing substantial equivalence to predicate devices based on material, configuration, function, manufacturing, packaging, and sterilization.

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

Here is what can be inferred or explicitly stated:

Information not available in the provided document for this device:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Extracted Information (where applicable):

1. A table of acceptance criteria and the reported device performance:
Not applicable. This device is a physical umbilical cord clamp, not a diagnostic AI/ML device. The submission establishes substantial equivalence rather than meeting specific performance metrics against acceptance criteria typical for AI/ML.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No "test set" in the context of an AI/ML device study is mentioned. The device was subjected to non-clinical biocompatibility testing.

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 applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance would relate to its structural integrity, sterility, and biocompatibility, which were assessed through non-clinical tests.

8. The sample size for the training set:
Not applicable.

9. How the ground truth for the training set was established:
Not applicable.

Summary of Nonclinical Tests and Results (as provided in the document):

• Tests: Biocompatibility (cytotoxicity, hemolysis)
• Result: "no problems noted"
• Testing body: An independent lab.

Conclusion: The provided document is for a traditional physical medical device (umbilical cord clamp) and not for an AI/ML device. Therefore, the questions related to AI/ML device evaluation (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission. The device demonstrates safety and effectiveness through substantial equivalence to predicate devices and results from non-clinical biocompatibility testing.

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