(24 days)
KYMCO ForU EQ35 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 EQ35 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 text is a 510(k) summary for the KYMCO ForU EQ35 scooter, a motorized three-wheeled vehicle intended for disabled or elderly persons. The document focuses on establishing substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary emphasizes "Substantial equivalence" to predicate devices, noting "minor differences in performance specifications... these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This implies that the device is deemed acceptable if its performance is comparable to the predicate devices and does not introduce new safety or effectiveness concerns, but specific quantitative acceptance criteria or a direct comparison table are not included.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary primarily discusses the description of the device and its predicate devices, not specific test data.
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)
This information is not provided in the document. As this is a 510(k) for a mobility scooter, it's unlikely to involve expert-established ground truth in the same way a medical imaging AI would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. This type of study design is irrelevant for a mobility scooter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As this is a mechanical device, the concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of the device (mobility scooter), "ground truth" would likely relate to objective performance metrics (e.g., speed, range, stability, turning radius) measured against product specifications or standards, rather than expert consensus on a diagnosis or pathology.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of what is available in the document regarding acceptance and substantial equivalence:
The document primarily states that the acceptance criteria for market clearance is "substantial equivalence" to legally marketed predicate devices.
The study that proves the device meets the acceptance criteria (i.e., substantial equivalence) is implicit in the 510(k) submission itself. The submission provides:
- Predicate devices: AVANTICARE SA4022 (K051538) and LERADO CHINA LIMITED ForU EQ30 (K072630).
- Intended use: Both the subject device and predicate devices are intended for indoor/outdoor transportation for disabled or elderly persons limited to a seated position.
- Device description: The KYMCO ForU EQ35 scooter is described as a battery-operated indoor/outdoor transportation vehicle controlled by a tiller handle and a thumb-operated potentiometer throttle control lever. This aligns with the general description of such devices.
- Comparison statement: The manufacturer asserts that "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This statement is the core of their argument for substantial equivalence.
While the document does not include a detailed study report with specific measurements, the FDA's clearance (AUG - 4 2008) indicates that the agency reviewed the information provided by KWANG YANG MOTOR CO., LTD. and determined that the KYMCO ForU EQ35 scooter is substantially equivalent to the predicate devices and thus meets the requirements for market clearance under the 510(k) pathway. This regulatory finding serves as the "proof" that the device meets the implicit acceptance criteria of not presenting new safety or effectiveness concerns compared to existing devices.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).