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The Freerider Model FR168-4 is a motorized scooter which provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

The Freerider Model FR168-4 is a motorized four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable tiller, and a seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be disassembled into five parts for transport in a car trunk. It is provided with a battery charger.

The provided text describes a 510(k) submission for the Freerider™ FR168-4 Electric scooter. However, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such data was not part of this specific submission.

The document indicates that adherence to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995" was the basis for showing substantial equivalence. This type of submission relies on demonstrating that the new device has "technological characteristics" and "use parameters" similar to a legally marketed predicate device (in this case, the Shoprider 114 -TE889).

To be clear, here's a summary based on the provided text's limitations:

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

   • Not applicable. The submission states that "Comparative performance testing and clinical evaluations were not submitted." The primary "acceptance criteria" for a 510(k) in such cases is demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to relevant guidance documents.

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. No comparative performance testing or clinical evaluations were submitted, so there is no "test set" in the context of device performance metrics.

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. No test set or ground truth in this context was established from device performance evaluation.

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

   • Not applicable. No test set was used for device performance evaluation.

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 device is an electric scooter and not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. This device is an electric scooter and does not involve algorithms for standalone performance evaluation in this manner.

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

   • Not applicable. The "ground truth" for this 510(k) submission essentially refers to the established safety and effectiveness of the predicate device (Shoprider 114 -TE889) and the engineering tests conducted according to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."

8. The sample size for the training set:

   • Not applicable. This isn't a machine learning/AI device, so there is no concept of a "training set" for performance evaluation.

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

   • Not applicable. No training set for performance evaluation was used.

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