The WU'S 4-WHEELED SCOOTER WT-T4D is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the WU'S 4-Wheeled Scooter, WT-T4D.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Safety: Electronic systems are the same as the predicate device (WU'S 4-WHEELED NEO SCOOTER WT-T3D (K032488)), which passed UL certification. Ensures same safety level.	All electronic systems between the new device (WT-T4D) and the predicate device (WT-T3D) are from the same suppliers and have passed UL certification (Electronic controller, batteries, and recharge).
EMC Compliance (Electromagnetic Compatibility): Meets standards for electrically powered wheelchairs, scooters, and their chargers.	Complies with EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995.
Intended Use: Provides mobility to persons restricted to a seated position.	Same intended use as the predicate device (WU'S 4-WHEELED NEO SCOOTER WT-T3D).
Weight Limit: Same as the predicate device.	Same weight limit as the predicate device.
Back Upholstery: Same as the predicate device.	Same back upholstery as the predicate device.
Maximum Speed: 4 mph.	Same maximum speed (4 mph) as the predicate device.
Safe Climbing Angle: 8°.	Same safe climbing angle (8°) as the predicate device.
Warranty Period: Same as the predicate device.	Same warranty period as the predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify a separate "test set" in the context of typical AI/machine learning studies. The "testing" referred to is performance testing for EMC compliance and a comparison study to a predicate device. For the EMC compliance, it's implied that the device itself underwent these tests. For the comparison, the direct "sample size" isn't a relevant metric in the way it is for clinical trials or AI validation.
Data Provenance: The document indicates that the testing was performed, but does not explicitly state the country of origin for the performance test data. The submitter is from China (Taiwan). The comparison is to a predicate device, which would largely be based on the specifications and certifications of that device. The clinical "data" in this context is the comparison to existing standards and a legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Experts: This type of medical device submission (510(k) for a scooter) does not involve expert consensus in the way a diagnostic AI might. The "ground truth" here is established by engineering standards and regulatory compliance (UL certification for electronics, and specific performance standards like ANSI/RESNA WC/Vol.2-1998 for physical performance). There are no enumerated "experts" establishing a ground truth in the sense of reviewing medical images or patient records. The FDA's review process itself involves experts in device regulation and safety.

4. Adjudication method for the test set:

Adjudication Method: Not applicable in the context of this device and submission. Adjudication methods like "2+1" or "3+1" are typically used in clinical trials or AI validation studies where multiple human readers interpret data, and discrepancies need to be resolved. This submission relies on direct compliance with engineering standards and comparison to a predicate device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a mobility scooter, not a diagnostic or prognostic tool that would typically involve human readers interpreting data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Standalone Performance: Not applicable. This device is a physical product (a scooter) with electronic components. Its "performance" is its functionality, safety, and compliance with standards, not an algorithm's output. While it has an electronic controller, the "standalone performance" isn't measured in the same way as a solely algorithmic device. The performance tests (EMC, speed, climbing angle, etc.) are inherent to the device itself.

7. The type of ground truth used:

Ground Truth: The "ground truth" for this device's safety and effectiveness is established by:
- Regulatory Standards: Compliance with specific industry standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-4-2, IEC61000-4-3 for EMC, and UL certification for electronics).
- Predicate Device Equivalence: The specifications and proven safety/effectiveness of the legally marketed predicate device (WU'S 4-WHEELED NEO SCOOTER WT-T3D). The new device is deemed "substantially equivalent" based on matching key safety and performance characteristics with the predicate device.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a "training set" for an algorithm. The device's design is based on engineering principles and the existing predicate device.

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

Training Set Ground Truth Establishment: Not applicable, as there is no "training set" for this type of device.

Summary

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K040968

APR 3 0 2004

NO. 225, YUAN-PIER ST., HSIN C TEL: 886-5-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

દ્ધ 510(k) SUMMARY "

Submitter's Name: WU'S TECH CO., LTD.

NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)

Tel: 88

Date summary prepared:

Device Name:

Aril 10, 2003

Proprietary Name: Common or Usual Name: Classification Name:

WU'S 4-Wheeled Scooter, WT-T4D Electrical Scooter Motor Three-Wheeled Vehicle, Class II, 21 CFR 890.3800

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-T3D (K032488)

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NO. 225, YUAN-PIER ST., HSIN CH FAX: 886-5-5382 TEL: 886-5-5382105 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw

Summary for substantial equivalence comparison:

The intended uses, weight limit, back upholstery, maximum speed 4 mph, safe climbing angle 8°, and warranty period between the new device WT-T4D and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured.

The major difference existing is 4-wheeled for new device WT-T4D and the 3-wheeled for the predicate device WT-T3D. Besides the overall dimension and the size of tires are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

WU'S Tech. Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Rescarch Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K040968

Trade/Device Name: WU'S 4-Wheeled NEO Scooter, WT-T4D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 10, 2004 Received: April 14, 2004

Dear Dr. Jen:

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. Ke-Min Jen

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 Office of Compliance at (301) 594-4659. 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 Manufacturers, 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510 (K) NUMBER ( IF KNOWN ): ): TBA DEVICE NAME: WU'S 4-WHEELED NEO SCOOTER, WT-T4D

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkerson

Division of General, Restorative. and Neurological Devices

510(k) Number K040968

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).