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The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.

The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers. The Go Go Elite Traveller Plus, Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or storing the unit.

The provided text is a 510(k) summary for a medical device (Go Go Elite Traveller Plus, Four Wheel Scooter). This type of document focuses on establishing substantial equivalence to a predicate device based on non-clinical testing and functional comparisons, not on fulfilling detailed acceptance criteria from a comparative effectiveness study of an AI device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to AI/algorithm performance studies which are not relevant to this submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantified acceptance criteria or reported performance in a table format as would be typical for an AI device study. Instead, it refers to compliance with established standards for wheelchairs and scooters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a submission for a physical medical device, not an AI algorithm. The testing involves compliance with physical standards, not data analysis on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment in the context of an AI algorithm from experts described in this document. The assessment is based on engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication for a test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "truth" in this context is defined by adherence to established engineering, safety, and performance standards for power scooters, rather than a clinical "ground truth" for an AI algorithm.

8. The sample size for the training set

Not applicable. This is not an AI device; there is no training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device; there is no training set or ground truth establishment in that context.

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