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• Any individual who needs a power wheelchair and can not stand up on their own such as people with Paraplegia, Spina Bifida, Cerebral Paresis, Multiple Sclerosis, Muscular Dystrophy, and Polio.
• Any individual to take part in sports activities requiring an upright position.

The ParaGolfer Standup Wheelchair is a front wheel drive powered standup wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The ParaGolfer Standup Wheelchair has a "U" frame, controlled by a Curtis Instruments Controller, electronic regenerative disc brakes and Micro Motor.

This document, a 510(k) summary for the "ParaGolfer Standup Wheelchair," does not describe an AI/ML-enabled medical device or any device that requires the kind of acceptance criteria, study design, and performance metrics typically associated with AI.

Instead, this document is a premarket notification to the FDA for a physical medical device (a wheelchair). The "acceptance criteria" discussed are compliance with established international and national standards for wheelchairs, not performance metrics of an algorithm. The "study" mentioned is conformity testing to these engineering standards, conducted by a testing body (TÜV Product Service), not a clinical trial or performance evaluation of an AI model against ground truth.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) because they are not relevant to this type of device and are not present in the provided text.

The closest information relating to "acceptance criteria" and "study" is:

• Acceptance Criteria/Study type: The ParaGolfer was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 Series (including 7176-20), and ANSI/RESNA WC Vol. 2 Section 21 Amendments 1998 for EMC.
• Reported performance: The conclusion was that "the test sample fulfills the requirements."

This type of information is entirely different from what would be provided for an AI/ML device.

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