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The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts.

The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.

Fogarty Corkscrew Catheters:
The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consisting of a polyvinylchloride outer catheter body surrounding a movable, radiopaque stainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cable covered by a latex membrane is attached to the distal end of the catheter. A handle to modulate the spiral cable diameter is attached to the inner spring body at the proximal end of the catheter. The spiral cable design of the Fogarty Corkscrew catheter increases the surface area for entrapping fibrous material.

Fogarty Graft Thrombectomy Catheters:
The Fogarty Graft Thrombectomy catheters are sterile, single use catheters designed to remove organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for dialysis access and synthetic grafts for iliofemoral bypass. During use, the control button on the device handle is grasped and moved forward and aft to cause the spiral wires at the distal end to extend or retract. The spiral wires are extended during passage of the device through a narrowed region of a vessel. The spiral wires are then retracted to facilitate occlusive material removal.

The provided text is a 510(k) summary for the Fogarty Corkscrew Catheters and Fogarty Graft Thrombectomy Catheters. This document details the regulatory clearance process for medical devices by demonstrating substantial equivalence to existing predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study proving an AI/algorithm-based device meets acceptance criteria.

The Fogarty Corkscrew and Graft Thrombectomy Catheters are physical, mechanical medical devices used for embolectomy and thrombectomy. The "Device Testing" section explicitly states: "Bench testing was performed in accordance with Edwards' design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed."

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI device based on the provided text, as the text pertains to traditional medical devices and their mechanical/biological performance, not AI performance.

If you have a different document describing an AI medical device, please provide that.

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