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The Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.

The Quingo Flyte Mobility Scooter is a battery powered indoor scooter. The vehicle uses a 5 (Five) wheel system comprised of 3 main wheels with two additional wheels to provide additional safety, stability and improved turning ability. Attached to the wheelbase are a padded seat, steering tiller, bars and electronic controls which allow the user to properly direct and control the vehicle. As the vehicle is battery powered a charging unit is included. To assist with loading into vehicles for transport an aluminium railing system which fits into most vehicles is provided along with a directly wired electronic control so that no disassembly is required and no heavy lifting by the user is needed.

The provided document, K171256 for the Quingo Flyte Mobility Scooter, is a 510(k) premarket notification and does not contain the information requested for acceptance criteria and a study proving device performance in the context of an AI/software as a medical device (SaMD).

This document demonstrates substantial equivalence to a predicate device (Kymco EQ 30) based on intended use, technological characteristics, and performance testing against ISO standards for mobility scooters, not clinical or diagnostic performance criteria as typically seen for AI/SaMD.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) from the provided text.

Here's why:

• Type of Device: The Quingo Flyte Mobility Scooter is a physical, mechanical device, not an AI/SaMD. The FDA's review process for such devices focuses on safety, mechanical performance, and substantial equivalence to existing devices through engineering tests and adherence to industry standards like ISO 7176.
• Absence of AI/SaMD-specific Information: The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This further confirms that the type of study, ground truth, expert involvement, and statistical metrics (like sensitivity, specificity, or effect size for human readers) typically associated with AI/SaMD performance validation are not present.
• "Acceptance Criteria" Context: For this device, "acceptance criteria" largely refer to meeting the requirements of the ISO 7176 standards listed, which are engineering and functional performance benchmarks (e.g., maximum speed, braking distance, weight capacity, stability, etc.), not diagnostic accuracy metrics.

In summary, the provided text does not contain the information necessary to fulfill your request regarding acceptance criteria and a study proving device performance for an AI/SaMD.

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