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The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) premarket notification letter from the FDA to AngioDynamics Inc. regarding their Percutaneous Introducer and VenCureEVLT Procedure Kit. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. The "Indications for Use" section describes what the device is intended for but does not provide performance metrics or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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