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The AngioJet Ultra XPEEDIOR Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥ 3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet Ultra XPEEDIOR Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra XPEEDIOR Thrombectomy Set is used with the AngioJet Ultra Console.

The provided text is a 510(k) summary for the AngioJet Ultra XPEEDIOR Thrombectomy Set, indicating that Possis Medical, Inc. considers the device to be substantially equivalent to previously cleared predicate devices.

However, the document does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes for testing, ground truth establishment methods, expert qualifications, or comparative effectiveness studies (MRMC) with specific effect sizes.

The "Functional and Safety Testing" section (page 4) broadly states: "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a general statement about the types of tests performed but lacks any specific results or details that would allow for filling out the requested table and information.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided.

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