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GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.

The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome. Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.

The GamCath® High Flow Dolphin® Catheter is a short-term hemodialysis catheter. The study provided does not describe a clinical trial with human subjects or a comparison to human performance or AI. Instead, the "study" is a series of non-clinical, benchtop tests designed to demonstrate substantial equivalence to predicate devices and ensure the device meets recognized safety and performance standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample sizes for each non-clinical test.
• Data Provenance: Not applicable. These were non-clinical, benchtop tests conducted to verify compliance with standards, not a clinical study involving human patients or real-world data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The ground truth for these non-clinical tests is based on established engineering and biocompatibility standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and the successful execution of validated test protocols by qualified personnel in a laboratory setting. There is no mention of expert consensus for interpreting test results in the way it would be established for clinical image analysis or diagnostics.

4. Adjudication Method for the Test Set

• Not applicable. As these are non-clinical, objective tests against established standards, an adjudication method for a "test set" (in the sense of a clinical or image-based evaluation) is not required. Test results are compared directly to the specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device, not an AI or diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is a combination of recognized industry standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and predefined engineering specifications for the device's performance characteristics (e.g., specific tensile strength values, acceptable pressure ranges, absence of leakage).

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI context, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI model, the method of establishing its ground truth is irrelevant here.

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