(28 days)
KYMCO ForU EQ10 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ10 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 a medical device called the "KYMCO ForU EQ10 scooter." This document is a premarket notification for a Class II medical device, primarily focused on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with defined endpoints.
Therefore, most of the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as specific quantifiable metrics required for clinical or performance evaluation. The "acceptance criteria" in this context are for demonstrating substantial equivalence to predicate devices, focusing on intended use, technology, and safety/effectiveness profiles.
- Reported Device Performance: The document states "There are minor differences in performance specifications of the scooters," but does not provide a table or specific details of these differences or the KYMCO ForU EQ10's measured performance against any pre-defined criteria.
| Acceptance Criteria (from a medical device performance study) | Reported Device Performance (KYMCO ForU EQ10) |
|---|---|
| Not specified as quantitative performance benchmarks for a study in this document. | The document broadly states "minor differences in performance specifications" compared to predicate devices, but no specific performance metrics or values are provided. |
2. Sample size used for the test set and the data provenance:
- There is no test set, sample size, or specific data provenance (country of origin, retrospective/prospective) mentioned for a performance study.
- The comparison is based on the technical specifications and intended use outlined in the 510(k) submission, not on a study with human subjects or a defined dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" and therefore no ground truth established by experts for a performance study. The 510(k) process relies on regulatory review of technical documentation and comparison to predicates.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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 electrical scooter for mobility, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device (scooter), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no "ground truth" established from clinical data or expert consensus for this 510(k) submission. The "truth" here is regulatory compliance and substantial equivalence to existing devices.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth establishment is relevant to this type of device and regulatory submission.
Summary based on the document:
The 510(k) submission for the KYMCO ForU EQ10 scooter focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (AVANTICARE SA4022 (K051538) and LERADO CHINA LIMITED ForU EQ30 (K072630)). The core argument is stated as: "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 document is a regulatory filing, not a scientific publication detailing a performance study with acceptance criteria and a study design as you've outlined. Therefore, most of your questions are outside the scope of the provided text.
§ 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).