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The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

very high-risk for management by traditional operative techniques l )

inoperable 2)

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature.

The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details for the Trufil! DCS Orbit Detachable Coil System Line Extension. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use. It does not include data from performance studies or clinical trials that would provide the specific information requested about acceptance criteria and how they were met.

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