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The WOLF Thrombectomy System, 14F is indicated for:
• The nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The WOLF Thrombectomy System, 14F is comprised of two single lumen variable stiffness catheters (WOLFcatheter & Devortex shaft) designed for use in removing clot from peripheral vessels. A funnel is attached to the distal end of the WOLF catheter to aid in ingestion of clot. The Devortex sleeve is attached to the Devortex shaft. When the Devortex shaft is pulled, it inqests the clot into the WOLF catheter. The WOLF catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.

The Devortex shaft has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The WOLF catheter has one radiopaque marker band at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion.

The WOLF Thrombectomy Sheath consists of a sheath, dilator and syringe. An active hemostatic valve is integrated at the proximal end of the sheath which can be manually opened for device introduction to provide hemostasis and minimize blood loss. The distal end of the sheath features a radiopaque marker forrecognition under fluoroscopy. The hemostasis valve is coupled with a large bore side port and is accompanied with a VacLok syringe for aspiration.

The provided document is a 510(k) summary for the WOLF Thrombectomy System, 14F. It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices through various performance tests. However, this document does not contain information related to an AI/ML device or its acceptance criteria and study results.

The document primarily focuses on the physical and mechanical properties of a medical device (a thrombectomy system) and its biocompatibility, sterilization, and packaging. It mentions "performance data" and "bench studies" that verify the device performs as intended with respect to its design inputs, including metrics like durability, integrity, kink resistance, and tensile strength. It also refers to "simulated use validation" and "animal testing" (primarily for the predicate device, with an acute study in an ovine model for radiopacity of the sheath).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text is about a physical medical device and does not involve AI or ML.

If you have a document describing an AI/ML medical device and its validation studies, please provide that, and I would be happy to assist.

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