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The DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit 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 40 cm are intended for femoral vein insertion. This catheter is indicated for > 30 days long-term placement.

The DuraFlow™ 2 Chronic Hemodialysis Catheter is a dual lumen. 15.5FR catheter and is available in multiple lengths, in straight configurations. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length step tip with side-holes. The distal venous lumen extends past the arterial lumen. The proximal section of the device contains a fixed polyester 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 ID tags clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a digital health device meets acceptance criteria. The document is a 510(k) summary for a physical medical device, the "DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit", and discusses its substantial equivalence to a predicate device based on non-clinical (i.e., laboratory) tests.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for a digital health device.
• Sample size used for a test set or data provenance for a digital health device.
• Number and qualifications of experts for ground truth establishment for a digital health device.
• Adjudication method for a digital health device's test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI assistance.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a digital health device.
• Sample size for the training set for a digital health device.
• How the ground truth for the training set was established for a digital health device.

The document focuses on the physical and functional characteristics of the hemodialysis catheter, such as tensile strength, flow rate, and leakage, to establish its safety and performance through non-clinical testing. It does not mention any digital health component, AI, or human-in-the-loop studies.

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