KYMCO ForU EQ10 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device Description

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.

AI/ML Overview

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.

Summary

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K082900

Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'K' inside an oval shape. The 'K' is formed by a thick vertical line on the left and a curved shape that resembles a crescent moon on the right. The logo is simple and uses a bold design, making it easily recognizable.

KWANG YANG MOTOR CO., LTD.

No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: +886-7-3822526 FAX: +886-7-3825834

510(k) Summary

OCT 2 8 2008

Device

Trade name: KYMCO ForU EQ10 scooter Common name: Electrical scooter Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II

Predicate devices

AVANTICARE SA4022 (K051538), LERADO CHINA LIMITED ForU EQ30 (K072630), KWANG YANG MOTOR CO. LTD.

Intend use of device

KYMCO ForU EQ10 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device description:

Substantial equivalence:

The KYMCO ForU EQ10 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) and ForU EQ30 (K072630) manufactured by LERADO CHINA LIMITED and KWANG YANG MOTOR CO. LTD., respectively.

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. Therefore, KWANG YANG MOTOR CO., LTD. believes that the KYMCO ForU EQ10 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEPARTMENT OF HEALTH & HUMAN

Kwang Yang Motor Co. Limited % Ms. Junnata Chang 14F-2 NO. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220

OCT 28 2008

Re: K082900

Trade/Device Name: KYMCO ForU EQ10 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 18, 2008 Received: September 30, 2008

Dear Ms. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Junnata Chang

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark W. Milburn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known):

Device Name: KYMCO ForU EQ10

Indications for Use: To provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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(Division Sign-Off Division of Genery I, Restorative, and Neurological رال الأوراز الأوراز والأ

510(k) Number _K081502

(Posted November 13, 2003)

viii

Regulation Number and Section

§ 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).