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When operated with a Rotarex S single use catheter, the Straub Endovascular System is intended for use as an atherectomy device and to break up and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, pulmonary, iliac or renal vasculature.

The Straub Endovascular System consists of:

• Rotarex®S catheter set which includes a Rotarex®S catheter, guidewire, collecting bag and drape. ● All are provided sterile and are for single use
• . Drive System, consisting of the Control Unit, Motor and Foot switch. The Drive System serves to drive and control the rotational catheters.
  Rotarex S is an over-the-wire, percutaneous catheter. The catheter consists of a flexible braided shaft, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings.
  The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with facets at its foremost tip, which when rotating, serve to abrade occluding material lying in front of it. Concomitantly, the rotation of the catheter head creates a vortex in the blood which assists to further erode occluding material from the vessel lumen. The detached material is aspirated into the side openings of the overlying cylinders where it is further broken down within the head and then carried through the inner lumen into a collecting bag outside of the body.

The provided text is a 510(k) Summary for the Straub Endovascular System, which is an atherectomy device. The document details the device's indications for use, its comparison to predicate devices, and a summary of performance testing and clinical evaluations.

However, the information provided does not contain the specifics required to answer your request about acceptance criteria and a study proving the device meets those criteria for an AI/ML medical device. The document describes a traditional medical device (an atherectomy system), and the testing outlined (bench validation, biocompatibility, sterilization, electrical safety, animal study, and a meta-analysis of clinical studies) are standard for such devices.

There is no mention of any AI/ML components, no acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, AUC), no test set details for AI/ML evaluation, no expert ground truth establishment, no MRMC study for AI assistance, and no standalone AI performance analysis.

Therefore, I cannot extract the information requested as it is not present in the provided text.

To answer your request, the document would need to describe a study that directly evaluates an AI/ML component of the Straub Endovascular System, including:

1. A table of acceptance criteria (e.g., minimum sensitivity, specificity, AUC, or other relevant AI performance metrics) and the reported device performance against these.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts used to establish ground truth for AI/ML.
4. Adjudication method for ground truth in an AI/ML context.
5. MRMC study details if human readers were assisted by AI, including effect size.
6. Standalone AI performance (algorithm only).
7. Type of ground truth (e.g., expert consensus on images, pathology results, patient outcomes) specifically for AI evaluation.
8. Training set sample size for the AI model.
9. How ground truth for the training set was established.

Based solely on the provided text, the device is evaluated through engineering verification tests, animal studies, and a meta-analysis of existing clinical data. These are not AI/ML specific evaluations.

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