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The blood tubing sets are intended for use with a blood access device and a medically approved flowthrough treatment device.

Medisystems blood tubing sets are used during extracorporeal procedures by providing a means to connect blood access devices to flow-through treatment device(s) (e.g. a hemodialyzer).

The provided text is a 510(k) summary for a medical device called "Arterial - Venous Blood Tubing Set." This document focuses on demonstrating substantial equivalence to a predicate device and details proposed labeling changes, rather than presenting a study with acceptance criteria and device performance metrics.

Therefore, the document does not contain the information required to answer your request. It does not describe:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Methods for establishing ground truth.

The document explicitly states: "Because the intent of this 510(k) is to seek FDA acknowledgment for a change in the labeling of currently marketed devices, the technological characteristics of the device are unchanged." and "The proposed labeling changes do not affect the product's design, composition, manufacturing, or performance characteristics." This indicates that no new performance studies were conducted or are being reported in this submission.

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