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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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MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.

MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria. The document is a 510(k) clearance letter for the MindMotionPRO device, which primarily concerns the FDA's determination of substantial equivalence to a predicate device.

The information you asked for, such as:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size and ground truth establishment for the training set

is not present in this document. This letter focuses on regulatory clearance and does not detail the technical validation studies of the device.

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