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THE MEDCOMP ULTRA-FLOW™ HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING ECHE 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. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

The Medcomp Ultra-Flow™ Catheter is a 14.5F polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification. The proposed device is a product line extension to the legally marketed device, ar identical in design and materials. The modifications include: 55cm length, Femoral insertion instructions for use.

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific quantitative acceptance criteria (e.g., "recirculation rate < X%"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices for recirculation and flow performance.

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

• Sample Size: Not specified. The document states "In-Vitro performance data for the proposed device."
• Data Provenance: In-vitro testing. No country of origin is mentioned, and it's not applicable as it's an in-vitro study, not clinical. The study is prospective in the sense that it was conducted for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This was an in-vitro performance study, not a study requiring expert readers or ground truth established by medical professionals.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication was involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed, though not an "algorithm" in the AI sense. The "device" (catheter) was tested in-vitro in a standalone manner to assess its physical performance characteristics (recirculation and flow).

7. Type of Ground Truth Used:

For this in-vitro study, the "ground truth" was established by measured physical performance characteristics (recirculation and flow rates) as compared to the performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device where a "training set" would be used in the traditional sense. The design and materials are stated to be "unchanged" from the predicate device, implying that the "learning" for the design was derived from the predicate's established performance.

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

Not applicable, as there is no training set in the context of an AI/ML device. The "ground truth" for the device's design implicitly comes from the established safety and effectiveness of the predicate devices.

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