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MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.

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This document is an FDA 510(k) clearance letter for the MindMotion™ GO device. It states the device's indications for use but does not contain information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication), or comparative effectiveness studies. Therefore, I cannot fulfill your request for that specific information based on the provided text.

The closest information provided is the "Indications for Use":

Device Name: MindMotion™ GO

Indications for Use (Describe): MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.

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