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The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in coniunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of acute clot in thrombosed dialysis grafts.

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Here's an analysis of the provided text regarding the Arrow-Trerotola™ Percutaneous Thrombolytic Device, with the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific target sensitivity or specificity). Instead, it focuses on demonstrating equivalency to a predicate device, the Angiodynamics Pro™ Infusion Catheter thrombolytic procedure, across several key outcomes for the clinical study.

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

• Sample Size: 122 patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the FDA approval suggests it's likely a US-based study, given the approving body. However, this is an inference, not a direct statement.
  • Retrospective or Prospective: Prospective (described as a "randomized study recently completed at six institutions").

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

The document does not provide information on the number of experts, their qualifications, or how the ground truth was established for the clinical study. It only states that the "results of this clinical trial support claims."

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the clinical trial results.

5. 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

• MRMC Study: No, this was not an MRMC study. The device is a mechanical thrombolytic device, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output.
• Effect Size of Human Readers with/without AI: Not applicable, as this is not an AI-assisted diagnostic device. The study compared the device to another mechanical thrombolytic procedure.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (a catheter and drive unit) used directly on patients, not an algorithm. Therefore, "standalone" in the context of an algorithm's performance is not relevant. The clinical study itself demonstrates the device's performance in its intended use.

7. The Type of Ground Truth Used

The "ground truth" was established through direct clinical outcomes in a randomized controlled trial. This includes:

• Acute technical patency rates (likely assessed by clinical observation or imaging post-procedure)
• Acute major complication rates (clinical observation and medical records)
• Procedure time (measured during the intervention)
• Any complication rates (clinical observation and medical records)
• 3-month clinical patency rates (follow-up clinical assessment, potentially with imaging).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, and the document describes a clinical trial (test set), not a machine learning model that requires a "training set."

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

Not applicable, as there is no machine learning "training set" in the context of this device.

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