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The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler with protective sheath.

This a Vaxcel™ Dialysis Catheter, which is a Class III medical device. There is no information in the provided text to calculate the performance of the device or the acceptance criteria. The document is simply a 510(k) summary and the FDA's clearance letter, stating that the device is substantially equivalent to a predicate device.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Data: The provided text does not include any acceptance criteria, performance metrics, or study results for the Vaxcel™ Dialysis Catheter itself. The "Summary of Substantial Equivalence" section only states: "The Vaxcel Dialysis catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is a high-level statement and does not detail the specific tests, their results, or the acceptance thresholds.
• Focus on Substantial Equivalence, Not Performance Study: The entire submission and the FDA's response revolve around the concept of "Substantial Equivalence" to a legally marketed predicate device (also named Vaxcel™ Dialysis Catheter) under 510(k) regulations. This means the manufacturer argued the new device is as safe and effective as the existing one, not necessarily that it met specific, newly defined performance criteria in a clinical study.
• No Clinical Study Details: There is no mention of a human clinical study, an AI component, or any details about sample sizes, expert involvement, ground truth, or adjudication methods for either a test or training set.
• Not an AI/Diagnostic Device: The Vaxcel™ Dialysis Catheter is a physical medical device (a catheter) for hemodialysis and apheresis, not a diagnostic algorithm or an AI-powered system that requires performance metrics like sensitivity, specificity, or reader studies.

Therefore, since the device is a physical catheter and the submission focuses on substantial equivalence rather than a detailed performance study against specific criteria, none of the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type, or training set details) can be provided from the given document.

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