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The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.

The Kendall LifeTrace Umbilical Blood Collection Device consists of a cup shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half contains an Angel Wing Transfer device that is used to facilitate the transfer of the collected blood from the top chamber to the tube.

This 510(k) summary (K032827) for the Kendall LifeTrace Umbilical Blood Collection Kit primarily focuses on establishing substantial equivalence to a predicate device based on shared intended use and technological characteristics, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully populated as the document does not describe a performance study in the way a typical AI/software device submission would.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of acceptance criteria and reported device performance in the context of a clinical or analytical performance study, as it is a 510(k) submission for a non-AI, non-software medical device. The "acceptance criteria" here relate to demonstrating substantial equivalence based on product characteristics and biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission describes an inert device for blood collection and focuses on substantial equivalence and biocompatibility, not performance on a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used

Not applicable in the context of evaluating diagnostic accuracy or a similar performance claim. The "ground truth" for this device relates to its physical and material properties meeting established standards (e.g., biocompatibility standards) and its functional similarity to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve a "training set" in the context of machine learning.

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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.

Ask a specific question about this device