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KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided 510(k) summary for the KYMCO ForU EQ40 scooter is part of a submission to demonstrate substantial equivalence to predicate devices, not an independent study aimed at proving device performance against specific acceptance criteria in the way a diagnostic AI device might.

Therefore, many of the typical sections requested for an AI device's acceptance criteria and study design are not applicable to this submission. This is a medical device (mobility scooter), and the regulatory pathway focuses on comparing its safety and effectiveness to already legally marketed devices, rather than establishing novel performance metrics.

Here's an analysis based on the information provided, highlighting why certain questions are not directly answerable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present in the 510(k) summary as the submission's goal is to demonstrate substantial equivalence to predicate devices, not to meet specific quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. The "performance" here refers to functional characteristics of a mobility scooter.

2. Sample size used for the test set and the data provenance

Not applicable. This is a physical medical device (mobility scooter). The "test set" would typically refer to a clinical study or a dataset for evaluating a diagnostic algorithm. For this device, testing would involve engineering and functional performance evaluations for safety and efficacy in line with industry standards, not a "test set" in the context of an AI/diagnostic study. The provenance of data would be from engineering tests and comparisons to predicate device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for a mobility scooter is its functional performance, safety features, and specifications (e.g., speed, range, weight capacity, braking effectiveness), not an expert consensus on interpreting images or patient data. These would be assessed through engineering and physical testing, likely by engineers and quality control personnel, possibly against relevant national or international performance standards.

4. Adjudication method for the test set

Not applicable. This concept is relevant for studies involving human interpretation (e.g., radiologists reviewing images). For a physical device like a scooter, performance and safety are typically evaluated against pre-defined specifications and standards through objective measurements, not by adjudication of subjective interpretations.

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 type of study is specific to diagnostic aids, particularly those involving AI, where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The KYMCO ForU EQ40 is a mobility scooter and does not involve human "readers" or AI assistance for diagnosis.

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

Not applicable. The KYMCO ForU EQ40 is a non-AI, non-diagnostic physical device. There is no algorithm to be tested in a standalone fashion.

7. The type of ground truth used

For a mobility scooter, the "ground truth" consists of objective performance metrics and safety standards. This would include:

• Engineering Specifications: Measured values like maximum speed, turning radius, battery life/range, weight capacity, climbing ability, brake effectiveness, stability, electromagnetic compatibility (EMC).
• Safety Standards: Compliance with relevant international and national safety standards for powered wheelchairs and scooters (e.g., ISO, ANSI/RESNA, UL).
• Predicate Device Comparison: Data from testing predicate devices or manufacturer specifications for predicate devices to demonstrate equivalence.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model. There is no "training set."

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

Not applicable. There is no training set for this type of device.

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