KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 by KUANN DAH INDUSTRY CO., LTD.

I'm sorry, but this document is a 510(k) clearance letter from the FDA for a motorized scooter. It details the regulatory approval process for the device, including its classification and indications for use.

However, it does not contain any information about:

Acceptance criteria or reported device performance metrics in the context of a study.
Sample sizes for test sets or their data provenance.
Number or qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is purely administrative regulatory correspondence.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuann Dah Industry Co., Ltd. c/o Dr. Jen. Ke-Min R.O.C. Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K031309

Trade/Device Name: KUANN DAH, COOL TANK Motorized Scooter, KS-4L320 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 19, 2003 Received: April 24, 2003

JUL 3 1 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 lisuing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice reguirements 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. 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,

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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Page_______ of __ 1 __

510 (K) NUMBER ( IF KNOWN ):__TBA D E V I C E N A M E : KUANN DAH, COOL TANK Motorized Scooter, KS-4L320

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 )

Mark N Mckenna

Division Sion. L. ison or General, Restorative and Neurological Devices

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).