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510(k) Data Aggregation
(205 days)
BIOGAMING LTD.
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
The YuGO device, developed by Biogaming Ltd. is a virtual reality platform used with the Microsoft Kinect motion sensing technology, which provides exercise programs for the body's lower and upper extremities. It allows physical therapists to define professional, supervised, and personalized exercise programs via video games or a virtual trainer.
The system was designed to serve a number of purposes:
Allowing the treating clinician a direct access to the training program performed at the patients' home. by determining the allowed movements. extent and difficulty levels of the training protocol.
Encourage physical therapy home-training through the use of camera- sensors, visualizing and promoting body movements using a game displayed on screen.
Collecting movement and performance related data from the home- user; analyzing it and instantly preparing a report on a designated website, to allow treating clinicians (the patients' Physical Therapist or a Physician) access to a "performance report", in order to monitor, adjust and otherwise modify the training protocol to suit the needs of the patient in his rehabilitation process.
The system includes three (3) main functions: Clinician Dashboard, Patient Interface and Reporting System. Using the Microsoft Kinect for Windows to track motion, the YuGo Patient Interface records performance metrics providing them to qualified medical professionals via the Clinician Dashboard, in the Reporting system. Medical professionals can monitor patients performance, assign or modify rehabilitation exercises in Patient Interface for their patients through the Clinician Dashboard allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
The provided text describes the YuGo system, a software device intended to support physical rehabilitation. However, the text does not include detailed acceptance criteria or a study describing the device's performance against those criteria.
The section "Performance Testing" on page 5-6 briefly mentions that "Software validation testing was conducted to verify that the device performs according to its specifications as described in the Software Requirements Specifications (SRS). The Software Test Description (STD) for the YuGo system presents the methodology for the validation and describes the test cases along with their acceptance criteria and the detailed test procedure. The STD also includes the test log (including individual grade of Pass/Fail)."
This statement indicates that acceptance criteria and performance data exist in the SRS and STD documents, but these documents are not provided in the given text. Therefore, I cannot extract the specific information requested in your prompt.
To answer your questions, I would need access to the Software Requirements Specifications (SRS) and the Software Test Description (STD) for the YuGo system.
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