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The Rex Medical Cleaner II Rotational Thrombectomy System permits mechanical declotting and removal of thrombi and emboli in synthetic dialysis grafts. The Embolectorny balloon component, located on the Cleaner II Device, may be used for subsequent Embolectorny procedures to remove embol and thrombi in the arterial system communicating with the synthetic dialynisor afte

The Rex Medical Cleaner II Rotational Thrombectorny System is a battery operated, hand held, wall contacting, rotational thrombectorny device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner II macerates clot into particulate size that is not harmful to the patient. The integrated Embolectorny balloon provides a means to remove macerated thrombi, as well as wall adherent thrombi, from the dialysis graft. If required, the Embolectomy balloon located on the Cleaner II device may be used to remove any additional thrombi or emboli from the patient after the initial thrombectorny procedure has been performed,

Here's an analysis of the provided text regarding the acceptance criteria and study for the Rex Medical Cleaner II Rotational Thrombectomy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing rather than acceptance criteria for clinical efficacy. The device's "performance" is primarily assessed against predicate devices through various engineering and material tests, demonstrating substantial equivalence.

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

• Sample Size: The document states that the "statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size." However, the specific number of devices tested for each test is not provided in this summary.
• Data Provenance: The tests are non-clinical, bench testing. Therefore, there is no country of origin for patient data or retrospective/prospective nature. It's laboratory-based testing.

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

• Not Applicable: This was a non-clinical, bench testing study. No human experts were used to establish ground truth for a test set in the context of clinical performance or image interpretation. The ground truth for the engineering tests would be derived from physical measurements and standards (e.g., ISO standards).

4. Adjudication Method for the Test Set:

• Not Applicable: There was no clinical test set requiring human adjudication.

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

• No: The document does not mention any MRMC comparative effectiveness study. The evaluation focused on substantial equivalence through engineering bench tests, not comparative clinical performance with human readers/intervention.

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

• Not Applicable: This device is a mechanical thrombectomy system, not an AI algorithm or software. Therefore, the concept of "standalone performance" in the context of human-in-the-loop for AI is not relevant here. The device's performance is inherently mechanical, and its effectiveness is measured directly through its physical operation and effect on clots in a laboratory setting.

7. The Type of Ground Truth Used:

• The ground truth for this device's evaluation was based on engineering standards and physical measurements. For example, the "Stall Torque Test" would have an engineering specification for acceptable torque; "Clot Maceration in Graft" would likely involve objective measures of clot breakdown and particulate size. These are derived from established scientific and engineering principles, often outlined in the referenced ISO standards (ISO 10555-1, ISO 10555-4).

8. The Sample Size for the Training Set:

• Not Applicable: This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

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

• Not Applicable: As there is no training set, this question is not applicable.

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