(206 days)
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.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.