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The AngioDynamics, Inc. DuraMax™ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include the subclavian vein as required.

Catheters greater than 40cm are intended for femoral vein insertion.

This catheter is indicated for > 30 days long-term placement.

The DuraMax® Chronic Hemodialysis Catheter and Procedure Kit is used to remove and return blood during Hemodialysis and aphaeresis. The catheter lumens are open at the distal tip and have a total of 4 side holes (two at venous tip, two at arterial tip). The distal venous tip extends beyond the arterial lumen and is tapered and curved to facilitate placement into vasculature. The distal tip also includes a guidewire lumen to facilitate insertion. The proximal section of the device contains a fixed cuff that allows for tissue in growth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with color-coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The catheter is packaged individually or as a basic kit that includes the necessary accessories to correctly insert the catheter.

The provided text does not describe any acceptance criteria or a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy. This document is a 510(k) premarket notification for a medical device (DuraMax® Chronic Hemodialysis Catheter and Procedure Kit), which focuses on demonstrating substantial equivalence to predicate devices rather than quantitative performance metrics against defined acceptance criteria typically seen in studies for AI/software devices.

Instead, the document states:

"The safety and performance of the DuraMax® Chronic Hemodialysis Catheter and Procedure Kit have been substantiated through extensive non-clinical testing including shaft tensile strength, joint strength, leakage, flow rate, and kit component compatibility, Results of testing show that the DuraMax® Chronic Hemodialysis Catheter and Procedure Kit can reliably perform as a conventional hemodialysis catheter for obtaining blood access for hemodialysis and apheresis. No new questions of safety or effectiveness have been raised."

This type of testing refers to engineering and biocompatibility tests, not clinical performance studies with specific outcome metrics or ground truth comparisons.

Therefore, I cannot provide the requested information in the detailed format as it pertains to AI/software performance studies. The document describes a medical device, not an AI/software device.

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