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The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The HemoCath II is radiopaque silicone, comprised of 2 single lumens used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focused on the HemoCath II device:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. The submission states, "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments." The testing involved in vitro performance data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical data or expert-based ground truth was established for a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical data or expert-based ground truth was established for a test set.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical catheter and not an AI-driven diagnostic or assistive tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter and does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance was established by comparison to the performance of legally marketed predicate devices through in vitro testing. There was no clinical ground truth established for this submission.

7. The sample size for the training set: Not applicable. There was no "training set" in the context of an AI/ML algorithm. The comparison was made against existing predicate device performance.

8. How the ground truth for the training set was established: Not applicable. The device is not an AI/ML algorithm requiring a training set with established ground truth. Its safety and efficacy were demonstrated by comparing its in vitro performance characteristics (flow rate, tensile strength) to those of already legally marketed predicate devices.

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