The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).

AI/ML Overview

The provided text describes a 510(k) summary for the VCS S3T scooter, which is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The summary primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of design, function, features, and compliance with non-clinical performance standards.

Based on the provided information, there is no study conducted to prove the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific device performance metrics.

Instead, the "acceptance criteria" can be interpreted as demonstrating compliance with established performance standards for wheelchairs and motorized scooters, and the "study" is the non-clinical testing performed against these standards.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 (Determination of static stability)	Compliant (Implied by "results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria")
ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 (Static, impact and fatigue strengths-Requirements and test methods)	Compliant (Implied as above)
ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters)	Compliant (Implied as above)
CISPR 11-1990 (Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement)	Compliant (Implied as above)
IEC 61000-4-2-1995 (EMC-Electrostatic discharge immunity test (ESD))	Compliant (Implied as above)
IEC 61000-4-3-1995 (EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test)	Compliant (Implied as above)
California Bureau of Home Furnishings 116 (Flammability Standards)	Compliant (Implied as above)

Important Note: The document states that "results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended." However, it does not provide the specific numeric data or detailed results of these tests for the VCS S3T scooter. It only lists the standards tested against.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. For non-clinical performance testing of a physical device, the "sample size" would typically refer to the number of devices tested. It is common for such tests to be performed on a small number of production units (e.g., 1-3 units). The document does not specify this.
Data Provenance: The testing was conducted by Vehicles Technology Co., LTD. in Taiwan, as indicated by the sponsor's and manufacturer's information. It is non-clinical performance testing.

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)

Not applicable. This information is relevant for studies involving subjective human assessment or interpretation (e.g., medical imaging, clinical diagnosis). For non-clinical performance testing against engineering standards, "ground truth" is established by the specifications defined in the standards themselves, and the testing is typically performed by qualified engineers or technicians in a testing laboratory without the need for expert consensus in the medical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this concept applies to studies with subjective human interpretations. For objective engineering performance tests, the results are typically determined by measurements against defined limits, not by adjudication among human readers.

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

No. This is not an AI-powered device or a diagnostic device. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

Not applicable. This device is a physical product (a motorized scooter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is represented by the specified limits and methodologies defined within the referenced international and national performance standards (e.g., ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings). The device is deemed to meet the criteria if its performance falls within the acceptable ranges and passes the tests defined by these standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set or AI/ML algorithm is involved.

Summary

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AUG 1 5 2005

( 05113 /

510(k) summary

510(k) Summary

VEHICLES TECHNOLOGY CO., LTD.

VCS S3T scooter

Sponsor's information: Cycling and Health Tech Industry R&D Center No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan, 40768 Contact person: Dr. Chang Wan-Lan Director of Testing Department Phone: +886-4-23501100 Facsimile: +886-4-23504590 e-mail: cwl@tbnet.org.tw Date prepared: April 22, 2005

Proprietary and Manufacturer information: VEHICLES TECHNOLOGY CO., LTD.

No. 238, San Tsun 1st , Yung Kang City, Tainan, Taiwan, 71072 Registration number: 3005037465 Contact person: Chun-Pi Shen, Manager Phone: +886-6-2436477 Facsimile: +886-6-2436479 e-mail: vcs.power@msa.hinet.net

Device

Trade name: VCS S3T 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

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Predicate devices

Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 3-Wheeled Electric Scooter, DK S320 k number: K033241 Date cleared: 11/10/2003

Intend use of device

VCS S3T scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device description:

The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity.

The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat.

It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).

Substantial equivalence:

The VCS S3T scooter is substantially equivalent to the Be-Mobile 3-Wheeled Electric Scooter, DK S320 (K033241) manufactured by TUNG DENG ENTERPRISE CO., LTD..

Analysis of comparison of design, function and feature of VCS S3T scooter to TUNG DENG DK S320 (K033241), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.

While there are minor differences in performance specifications of the scooters,

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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, Vehicles believes that the VCS S3T scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

Non-Clinical testing

VCS S3T scooter has been tested to wheelchair standards. They include:

(1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
(2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
(3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
(4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement
(5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
(6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
(7). California Bureau of Home Furnishings 116 Flammability Standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2005

Vehicles Technology Co., LTD. c/o Dr. Chang Wan-Lan Director of Testing Department Cycling and Health Tech Industry R&D Center No. 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768

Re: K051131

Trade/Device Name: VCS S3T Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 6, 2005 Received: July 11, 2005

Dear Dr. Wan-Lan:

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- Dr. Chang Wan-Lan

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and if you is ought mains of substantial equivalence of your device to a legally premaince notification. "The start 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millherson

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

Enclosure

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Device descriptive information

3.1 Statement of indication for use

Statement of Indications for Use

510(k) Number (if known): _K051131

Device Name: VCS S3T

Indications for Use:

The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended 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 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Mark A. Milleson

General. Restorative d Neurological Devices

(Posted November 13, 2003)

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).