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a single use only, cord blood sampling, transfer device.
The Umbilicup is suitable for vaginal delivery and caesarean delivery.
The Umbilicup reduces blood exposure and aids in blood gas collection and transport.

A blood collection/transfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "DeRoyal Surgical, Umbilicup." This document primarily addresses the substantial equivalence of the device to a predicate device and regulatory compliance.

It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any clinical study results.

The document states the "Indications for Use Statement" and a brief description of the device: "a single use only, cord blood sampling, transfer device... reduces blood exposure and aids in blood gas collection and transport." However, it does not provide any data or study details to support these claims beyond the device's design and intended function.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, ground truth details, MRMC study, etc.) from the provided text.

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