WU'S 4-WHEELED NEO SCOOTER, WT-L4 by WU'S TECH CO., LTD.

Please Note: The provided text is a 510(k) clearance letter from the FDA for a device called "Wu's 4-Wheeled Neo Scooter, WT-L4." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about specific acceptance criteria studies, performance metrics, or study methodologies that would be found in a clinical trial report or a comprehensive device performance study.

Therefore, the following response will indicate where the requested information is not available in the provided document and will attempt to infer or state general principles where possible.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in this document.	Not specified in this document.
(Typically involves safety, functional performance, durability, etc., for a mobility device)	(Performance data and benchmarks are not detailed in an FDA clearance letter.)

Explanation: The FDA 510(k) clearance letter confirms substantial equivalence. It does not typically detail the specific acceptance criteria and performance data from validation studies. This information would be found in the 510(k) submission itself, including device testing and performance data submitted by the manufacturer to demonstrate safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in this document.
Data Provenance: Not specified in this document.
- The manufacturer is "Wu's Tech Company, LTD." from Hsin-Chu City, China (Taiwan). Any testing would likely involve participants or data from that region or other regions where testing was conducted.
- The document does not indicate if data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable and not available in the context of this device.
- This question is typically relevant for AI/ML-driven diagnostic devices where human experts establish ground truth for image or data interpretation.
- For a motorized scooter, "ground truth" would refer to objective performance metrics (e.g., speed, range, stability, braking distance, weight capacity) measured against engineering specifications and industry standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable and not available in the context of this device.
- Adjudication methods (like 2+1 or 3+1) are primarily used in diagnostic studies involving expert interpretation of medical images or data where discrepancies need to be resolved to establish ground truth.
- For a physical device like a scooter, performance would be assessed through objective measurements and user outcome studies, not through expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done, nor is it relevant for this device.
- MRMC studies are specifically designed for evaluating diagnostic accuracy, particularly with AI assistance in image interpretation, comparing human readers with and without AI.
- This device is a mobility scooter, not a diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm only) performance study was not done, nor is it relevant for this device.
- This concept applies to AI algorithms that operate independently to perform a diagnostic or analytical task.
- The Wu's 4-Wheeled Neo Scooter is a physical, user-operated device; it does not involve algorithms in the sense of a standalone diagnostic or analytical tool.

7. The Type of Ground Truth Used:

Not explicitly stated in the document.
Inferred Ground Truth: For a motorized three-wheeled vehicle like a scooter, the "ground truth" for demonstrating safety and effectiveness would involve a combination of:
- Engineering specifications and objective measurements: Testing against established standards for stability, braking, speed, range, weight capacity, battery life, turning radius, electromagnetic compatibility, etc.
- Clinical performance/user outcomes: Potentially studies on user comfort, ease of use, maneuverability, and safety in real-world or simulated environments, compared to predicate devices or established benchmarks for mobility.
- Material and component testing: Ensuring all parts meet quality and safety standards.

8. The Sample Size for the Training Set:

Not applicable and not available in this document.
- A "training set" refers to data used to train an AI/ML algorithm. This device is not an AI/ML algorithm.
- If any user studies were conducted for safety or performance, they would have a "study population" or "test subjects," but this is distinct from a "training set" in the AI context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable and not available in this document.
- As this is not an AI/ML device, there is no "training set" or ground truth established for it in that context.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wu's Tech Company, LTD. Ke-Min Jen. Ph.D. c/o Roc Chinese-European Industrial Research Soc. No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan)

Re: K013763

Trade Name: Wu's 4-Wheeled Neo Scooter, WT-L4 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 10, 2002 Received: July 16, 2002

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

JUL 3 0 2002

Image /page/0/Picture/11 description: The image shows a partial view of the Department of Health & Human Services USA seal. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or movement. The image is in black and white.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Mark N. Millers

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

510 (K) NUMBER ( IF KNOWN ): _ TBA

WU'S 4-WHEELED NEO SCOOTER, WT-L4 DEVICE NAME:

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use _

Over - The - Counter - Use_

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

for Mark n Milhuan
(Division Sign-Off)
Division of General, Restorative

neral. Restorative and Neurological Devic

510(k) Number -

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).