WU'S POWERED WHEELCHAIR, MAMBO 5 by WU'S TECH CO., LTD.

This document is a 510(k) clearance letter from the FDA for the WU'S Power Wheelchair, MAMBO 5. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML medical devices.

Medical devices like power wheelchairs are regulated differently from AI/ML software. Their "acceptance criteria" primarily relate to performance standards, safety, and functional requirements, which are typically established through engineering tests, usability assessments, and predicate device comparison, rather than clinical studies with ground truth established by experts.

Therefore, most of the requested information regarding AI/ML device studies, ground truth, expert consensus, and sample sizes for training/test sets is not applicable to this document. The document confirms market clearance based on substantial equivalence to a predicate device.

Here's what can be extracted based on the nature of the device and the document provided:

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

Not explicitly provided in this document. For a power wheelchair, acceptance criteria would typically involve:
- Safety standards: e.g., electrical safety, mechanical stability, braking effectiveness.
- Performance standards: e.g., maximum speed, range per charge, weight capacity, obstacle climbing ability, turning radius, durability.
- Usability: ease of operation, comfort.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device meets the same performance and safety standards as those predicates. Therefore, the "reported device performance" is essentially congruent with that of existing compliant power wheelchairs.

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

Not applicable / Not provided. This information is relevant for clinical studies or AI/ML model validation, not for the regulatory clearance of a physical medical device like a power wheelchair. Testing for a wheelchair would involve engineering and performance tests on the device itself, not a "test set" of patient data.

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 / Not provided. "Ground truth" established by experts is a concept for evaluation of diagnostic or AI/ML tools. For a power wheelchair, ground truth is established by physical measurement, engineering standards, and user testing.

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

Not applicable / Not provided. Adjudication methods are used in clinical trials or expert reviews, not typically for the direct testing of a physical device like a wheelchair.

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 was not done and is not applicable. MRMC studies are specifically for evaluating AI/ML-assisted diagnostic tools where "human readers" (e.g., radiologists, pathologists) interpret data. This device is a power wheelchair.

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

No, this was not done and is not applicable. This concept pertains to AI/ML software performance. The "algorithm" of a power wheelchair is its mechanical and electrical design, not a diagnostic algorithm.

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

For a power wheelchair, ground truth would be based on:
- Engineering standards: e.g., ANSI/RESNA standards for wheelchairs and scooters.
- Physical measurements and tests: e.g., measuring speed, stability, battery life, weight capacity.
- Usability assessments: observing users operating the device.
- Safety compliance: ensuring adherence to electrical, mechanical, and fire safety regulations.
The document implies that these types of "ground truth" (i.e., compliance with relevant standards and predicate performance) were met implicitly through the substantial equivalence determination.

8. The sample size for the training set

Not applicable / Not provided. This is irrelevant for a physical mechanical/electrical device.

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

Not applicable / Not provided. This is irrelevant for a physical mechanical/electrical device.

In summary, this FDA clearance letter for a power wheelchair does not contain the information requested because the device type and regulatory pathway are fundamentally different from those applicable to AI/ML medical devices where such detailed study and ground truth information would be available. The clearance is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, meaning it performs as safely and effectively as similar devices already on the market, meeting established safety and performance standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

APR 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030709

Trade/Device Name: WU'S Power Wheelchair, MAMBO 5 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 26, 2003 Received: March 6, 2003

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.

{1}------------------------------------------------

Page 2 - Dr. Jen Ke-Min

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.

R. Mark N. Millerson

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

{2}------------------------------------------------

Page 1 of _ 1 _

510 (K) NUMBER ( IF KNOW ): __ TBA ___________________________________________________________________________________________________________________________________________ DEVICE NAME: WU'S POWER WHEELCHAIR, MAMBO 5

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use	OR	Over - The -- Counter - Use_
( Per 21 CFR 801.109 )(Division Sign-Off)Division of General. Restorativeand Neurological Devices510(k) Number		( Optional Format 1-2-96 )ה בריירה ב-1747 לפני 1972 ב-1999 ב-1999 ב-1999 (1999) 1999 - 1999 (1999) 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

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).