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GamCath® catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. Not for pediatric use.

The catheter is a device, which can be used for short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis via the jugular, subclavian or femoral veins. The catheter is available in 13 French (4,3 mm / 0,169") straight configuration with the following insertion length: 125mm (4,921"), 150mm (5,906"), 175mm (6,900"), 200mm (7,874") and 250mm (9,843"). The catheter body and hub (bifurcation) is made from aliphatic polyurethane. The catheter body and hub is radiopaque (filled with Barium Sulfate). The catheter body has two lumens positioned side by side. The cross section of the venous lumen is elliptical and the cross section of the arterial lumen is kidnev-shaped. The arterial lumen is beveled. The venous lumen extends beyond the arterial lumen with a rounded tip. The arterial and venous extension line is made from transparent aliphatic polyurethane, which is connected to the hub. On each extension line there is a clamp with safety insert. The clamps are color coded to indicate the arterial lumen (red) and venous lumen (blue). The insertion length, diameter and priming volume are printed on the safety inserts. The Luer-Lock connectors are made from rigid PVC connected to the extension line. The Luer-Lock connector is protected with a Luer-Lock protection cap. A stylet made of FEP is provided in the venous lumen for insertion. A rotary suture ring is assembled with the hub (bifurcation) for fixation of the device. The brand name of the device is printed on the hub (bifurcation).

The provided text describes a 510(k) summary for the GamCath® High Flow Catheter. It outlines the device's characteristics, intended use, and a claim of substantial equivalence to predicate devices based on performance data. However, the document does not contain specific acceptance criteria or a detailed study report with the type of information requested in the prompt.

The document states: "The performance data demonstrate that the GamCath® High Flow Catheter is substantially equivalent to the predicate devices currently available on the market. The tests were performed per Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 03/16/95."

This indicates that a study was performed, but the results of that study, including the acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies, are not detailed in the provided text.

Therefore, I cannot fill out the requested table and answer the study-related questions from the provided information. The text only confirms that "performance data" was generated and that it supported the claim of substantial equivalence based on a specific FDA guidance document.

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