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The Opti-Flow Dual Lumen Catheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.

The Vas-Cath Opti-Flow catheter is a polyurethane catheter which allows for dialysis. hemoperfusion or apheresis. It has two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. A removable suture wing is available for securing the catheter after initial placement. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during longer term placement.

The cross-section of the shaft consists of two "D"-shaped arterial and venous lumens, separated by the straight part of the "D". The venous lumen extends beyond the arterial lumen and ends with a 45 degree beveled tip. The Opti-Flow catheters are available in 19 cm, 23 cm, 27 cm, and 35 cm insertion lengths. The Opti-Flow catheter is also available with a VitaCuff& antimicrobial cuff which helps to provide protection against catheter related infections and helps anchor the catheter during the initial fow weeks of placement.

I am sorry, but the provided text only describes the Vas-Cath Opti-Flow® Long Term Dual Lumen Hemodialysis Catheter and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria and study design for an AI/ML powered device. Therefore, I cannot generate the requested table and detailed study information.

The document is a 510(k) summary for a medical device (a hemodialysis catheter) that was submitted to the FDA in 1998. It predates the widespread use of AI/ML in medical devices and, therefore, does not discuss acceptance criteria or study designs related to AI performance.

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