The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.

Device Description

The VCS S4T 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 pertains to a 510(k) premarket notification for a medical device, specifically the VCS S4T scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with ground truth.

Therefore, most of the information requested in your prompt related to clinical studies, acceptance criteria tables, sample sizes, expert ground truth establishment, adjudication methods, and MRMC studies is not available within this 510(k) summary.

Here's an explanation of why and what information can be extracted:

Why the requested information is largely absent:

510(k) Substantial Equivalence: The 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It doesn't typically require new clinical studies to establish safety and effectiveness from scratch. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a predicate. Performance data often involves engineering testing or comparisons of specifications, not extensive clinical trials with human subjects to determine diagnostic accuracy against a "ground truth."
Device Type: The VCS S4T scooter is a "Motorized three-wheeled vehicle" (an electrical scooter). For such devices, acceptance criteria usually relate to safety standards (e.g., electrical safety, braking, stability), performance specifications (e.g., speed, range, turning radius, weight capacity), and durability, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI/imaging devices.

Information Extracted from the provided text:

Acceptance Criteria & Reported Device Performance:
- The document explicitly states: "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 implies that the acceptance criteria are implicitly met if the device's performance specifications are comparable to or within acceptable deviations from the predicate device (Bewell SC 20).
- However, no specific table of quantitative acceptance criteria values or the reported performance metrics of the VCS S4T scooter are provided in this summary. The document only makes a general statement of equivalency in performance.
Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. This 510(k) summary does not describe a "test set" in the context of clinical or AI performance evaluation. The substantial equivalence argument is based on comparing the device's design and specifications to a predicate.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. Ground truth establishment is not relevant for this type of device and submission.
Adjudication Method for the Test Set:
- Not applicable/Not provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is typically for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images). This is a mobility scooter, so such a study would not be relevant.
Standalone (Algorithm Only) Performance Study:
- No. This refers to AI algorithm performance without human intervention. The device is a physical mobility scooter; there is no "algorithm only" performance separate from the user.
Type of Ground Truth Used:
- Not applicable/Not provided.
Sample Size for the Training Set:
- Not applicable/Not provided. There is no "training set" for an AI model mentioned.
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided.

Summary Table of Unavailable Information:

Information Requested	Status (Not Applicable/Not Provided)	Explanation
Table of Acceptance Criteria & Reported Performance	Not Provided	The document states "minor differences in performance specifications" to the predicate, implying performance met acceptance, but no specific values or a table are presented. The 510(k) focuses on substantial equivalence, not detailed performance data.
Sample size (test set) & Data Provenance	Not Applicable/Not Provided	This type of 510(k) for a mobility scooter does not involve clinical "test sets" for diagnostic accuracy.
Number of Experts (ground truth) & Qualifications	Not Applicable/Not Provided	Not relevant for this device type.
Adjudication method (test set)	Not Applicable/Not Provided	Not relevant for this device type.
MRMC Comparative Effectiveness Study	No	Not relevant for a mobility scooter.
Standalone performance study	No	Not relevant for a mobility scooter.
Type of ground truth	Not Applicable/Not Provided	Not relevant for this device type.
Sample size for the training set	Not Applicable/Not Provided	Not relevant, as this is not an AI device with a training set.
How ground truth for the training set was established	Not Applicable/Not Provided	Not relevant, as this is not an AI device with a training set.

In conclusion, this 510(k) submission successfully establishes substantial equivalence for the VCS S4T scooter to a predicate device (Bewell SC 20) based on intended use and comparable technological characteristics, but it does not contain the detailed performance study information typically associated with AI/diagnostic devices that require "acceptance criteria" and "ground truth" as described in your prompt.

Summary

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K052558
TR

Vehicles Technology Co. I

No. 238, San Tsun 1st, Yung Kang City, Tainan, Taiwan Fax: +886-6-2436479 e-mail: vcs.power@msa.hinet.net Tel: +886-6-2436477

510(k) Summary

Device

Trade name: VCS S4T scooter

Common name: Electrical scooter

907 % 7 410

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: 89INI

Classification: Class II

Predicate devices

Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device

VCS S4T 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 VCS S4T scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.

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, Vehicles Technology believes that the VCS S4T scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Public Health Service

OCT 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chang Wan Lan Cycling and Health Tech Industry R&D Center/CHC No. 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 407

Re: K052558

Trade/Device Name: VCS S4T Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 12, 2005 Received: October 18, 2005

Dear Chang 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 cnactment 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 -Chang Wan Lan

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your to organ finding of substantial equivalence of your device to a legally premaired predicated 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 rr you desire specific aarnoliance at (240) 276-0120. 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 Echoral International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Signature

Cor 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): K052558

Device Name: VCS S4T

Indications for Use:

The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.

Prescription Use __________ Over-The-Counter Use _ X (Part 21 CFR 807 Subpart C) (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) Page 1 of 1

Signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KoSZS K

(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).