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The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

The TiPower TR Rim Power and TiPower TRA RimPower are rigid power/manual titanium wheelchairs.

The provided document describes a 510(k) summary for the TiPower TR RimPower and TiPower TRA RimPower wheelchairs, which are power/manual wheelchairs. It details the device, its intended use, and comparison to a predicate device. The document also includes an FDA clearance letter.

However, the provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The "Testing Results" section only states: "Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable) and ANSI/RESNA WC/Vol. 2-1998 Section 21 and EN 12184:1999." This indicates that the device underwent testing according to these recognized standards, and the results met their requirements, but it does not provide the specific numerical acceptance criteria or the detailed performance data.

Therefore, I cannot fulfill your request for an acceptance criteria table or information about the study's methodology as the necessary details are not present in the provided document.

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