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The EndoSonics Trak Back is intended for use as a pull back accessory to the EndoSonics Intravascular Ultrasound Imaging Catheters. The Trak Back Device withdraws the imaging catheter from the vessel through the guide catheter.
The Trak Back can be used with the Visions Five-64 series ultrasound imaging catheter. The Trak Back withdraws the imaging catheter from the vessel through the guide catheter.

The Trak Back is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Trak Back has a nominal linear travel distance which is only limited by the catheter length, and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Trak Back has no direct patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment.

The provided text is related to a 510(k) Premarket Notification for the EndoSonics Trak Back Device, an accessory for intravascular ultrasound imaging. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets the acceptance criteria, based on the provided text.

The document is a regulatory submission for a medical device and primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against specific criteria.

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