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The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn's umbilical cord. The clipper jaws are placed over the "hinge" area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.

Precision Dynamics Corporation purchases the packaged umbilical cord clamp clipper (non-sterile) from DeRoyal Industries. Precision Dynamics Corporation upon receipt of the non-sterile finished product from DeRoyal Industries plans to distribute this device as the Securline ® Umbilical Cord Clamp Clipper.

The provided text is a 510(k) summary for the Securline® Umbilical Cord Clamp Clipper. It describes the device, its intended use, and indicates that it has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations. The document is a regulatory submission summary and an FDA clearance letter, not a study report.

Therefore, I cannot answer your request based on the provided input.

To provide the requested information, the input would need to include details of studies conducted to evaluate the device's performance against specific acceptance criteria.

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