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The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.

The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.

This document describes the GlidePath™ Retro Long-Term Hemodialysis Catheter. It addresses the performance data and comparison to predicate devices, but does not describe a study involving an AI medical device or clinical performance data that would typically include acceptance criteria and reporting on sensitivity, specificity, or other performance metrics for an AI algorithm.

Therefore, I cannot provide the information requested in your prompt regarding AI device acceptance criteria and study details because the provided text is for a traditional medical device (a catheter) and does not contain information about an AI-powered device or its performance study.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through non-clinical testing of various physical and functional characteristics.

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