The WU'S Powered Wheelchair MAMBO 36X 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

The provided text describes a 510(k) premarket notification for a powered wheelchair, the WU's POWERED WHEELCHAIR, MAMBO 36X. This document focuses on establishing substantial equivalence to a legally marketed predicate device, the TEH LIN JUPITER Powered Wheelchair TL-320 (K022697), rather than detailing acceptance criteria and performance data from a specific study designed to "prove the device meets acceptance criteria" in the way one might expect for a novel AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth details, training set size) are not applicable or cannot be extracted directly from this type of regulatory submission for a powered wheelchair.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Acceptance Criteria and Study for WU's POWERED WHEELCHAIR, MAMBO 36X

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a de novo approval or clinical trial for a novel device. Therefore, the "acceptance criteria" are largely based on meeting established standards and demonstrating similarity in safety and performance to the predicate device. The "study" referenced is the performance testing against these standards, which are not designed to measure metrics like sensitivity, specificity, or accuracy (which are common for AI/SaMD devices).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Criterion	Reported Device Performance/Comparison to Predicate
Intended Use	Same as predicate device.	The intended use between the two devices is the same: "to provide mobility to persons restricted to a seated position."
Design/Structure	Mainframes are foldable, similar materials, same suspension (cross brace).	Mainframes of both devices are foldable. Mainframe materials "all meet the strength and fatigue tests and they are similar for the material aspects." The suspension of the cross brace is the same.
Components	Same type of armrest, same back upholstery material, same electronic systems.	The two devices used the same type of armrest. Back upholstery material is the same fabric. Electronic systems (controller, batteries, charger) are from the "same suppliers" and "all passed by the UL certificated."
Safety (Electrical/Mechanical)	Complies with relevant electrical safety and wheelchair performance standards.	Demonstrated through compliance with: - EMC Report ANSI / RESNA WC/Vol.2-1998: Standard for electrically powered wheelchairs, scooters, and their chargers - requirements and test methods. - CISPR 11: 1990: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement. - EN61000-3-2: 1995: Limits for harmonic current emissions. - IEC61000-3-3: 1995: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems. - Electronic systems are UL certified.
Minor Differences (Not impacting safety)	Differences in overall dimensions, seat size, weight limit, speed, range, incline.	The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees. The overall appearance differences are "not safety aspect" and do not affect substantial equivalence.

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

Sample Size: Not applicable in the context of this 510(k) for a powered wheelchair. Performance testing refers to engineering and electrical safety standards applied to the device itself (e.g., a sample unit of the wheelchair), not a patient-based test set or data set in the manner of AI/SaMD.
Data Provenance: Not applicable. The "data" here are test results from engineering and electrical safety evaluations of the device's physical and electrical characteristics.

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

Not applicable. Ground truth, in the AI/SaMD context, refers to a definitively correct label or outcome for a medical condition. For a powered wheelchair, "ground truth" relates to compliance with engineering standards, which is assessed through standardized testing and certification by notified bodies (e.g., UL, and compliance to standards like ANSI/RESNA).

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for reconciling discrepancies in expert opinions on medical data, which is not part of this type of device submission.

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 is a powered wheelchair, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists).

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

Not applicable. This device does not involve a standalone algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable in the typical medical imaging/AI sense. The "ground truth" for this device is based on established engineering and electrical safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC) as assessed through physical and electrical performance tests. Successful passing of these tests serves as the "truth" that the device meets the safety and performance requirements.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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ITD K0500

NO. 225. YUAN-PIER ST. TEL: 886-3-5382105 FAX : 886-3-539 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

FEB 1 1 2005

66 510(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:

December 30, 2004

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S POWERED WHEELCHAIR, MAMBO 36X POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860

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, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)

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NO. 225, YUAN-PIER ST., HSIN CHU C TEL: 886-3-5382105 FAX: 886-3-538 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw

Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are foldable. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The suspension of cross brace is the same. The two devices used the same type of armrest. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, Thus the same safety level for the two devices is assured. batteries, and recharge.

The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees is differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 2005

WU's Tech. Co., L.T.D. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300

Re: K050010

Trade/Device Name: WU's Power Wheelchair, Mambo 36X Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: January 31, 2005 Received: February 3, 2005

Dear Dr. Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for too bearing 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 r ou may, dicterere, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 n may of basjon to back 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 that I Dr Hoal statutes and regulations administered by other Federal agencies. You must or any I oderal bather and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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) I his icher will anow you to ough finding of substantial equivalence of your device to a legally prematics notification. " " 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 If you desire spoolite acrise is (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 general mionnaational 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,

Mark A. Millman

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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Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: WU'S POWER WHEELCHAIR, MAMBO 36X

Indications for Use:

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

AND/OR Over-The-Counter Use Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number K030010

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).