The TEH LIN Power Scooter, TL-822 is an indoor / outdoor Power Scooter that is It has a base with four-wheeled with a seat. battery operated. 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) submission for the TEH LIN Power Scooter, TL-822. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than full clinical efficacy studies with acceptance criteria based on patient outcomes.

Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria for device performance in a clinical or diagnostic context, nor does it detail a study that proves the device meets such criteria.

Specifically, the document discusses:

Device Description: The TEH LIN Power Scooter, TL-822, is an indoor/outdoor, four-wheeled, battery-operated scooter for mobility.
Intended Use: To provide mobility to persons restricted to a seated position.
Performance Testing: It mentions "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" which are standards related to electromagnetic compatibility and wheelchair/scooter requirements. These are engineering and safety standards, not clinical performance acceptance criteria.
Substantial Equivalence: The primary focus is on establishing substantial equivalence to a predicate device (TEH LIN POWERED SCOOTER TL-588, K022698) based on having the same intended use, technological aspects, and only minor differences in appearance, dimensions, wheel size, maximum speed, and weight limit. The document explicitly states that "these differences for the two devices do not lead to any performance differences."

Based on the provided text, I cannot complete the table or answer the specific questions as they pertain to clinical or diagnostic performance criteria and studies, which are not detailed in this 510(k) summary.

Here's a breakdown of why each specific point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: The document only mentions adherence to safety/engineering standards (EMC/RESNA) and asserts that the differences from the predicate device do not lead to performance differences. There are no measurable "acceptance criteria" for clinical performance (e.g., accuracy, sensitivity, specificity) and no reported device performance against such criteria.
Sample size used for the test set and the data provenance: No test set (in a clinical sense) is described. The "performance testing" mentioned refers to engineering standards, not typical clinical study data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set or ground truth establishment is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices, not mobility scooters.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/software performance.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

No. 7, Wu Chuan 7th Road, WuKu Industrial Park,

Taipei County, Taiwan R.O.C.

Telephone: 886-2-22991901 Fax: 886-2-22991030 E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw

SEP 2 4 2004

K092012

July 22, 2004

દ દ 510(k) SUMMARY "

Submitter's Name: TEH LIN Prosthetic & Orthopaedic Inc.

No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C.

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

TEH LIN Power Scooter, TL-822 Power Scooter Motorized 4-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, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)

Legally marketed device for substantial equivalence comparison: TEH LIN POWERED SCOOTER TL-588 (K022698)

T11

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TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

No. 7, Wu Chuan 7th Road, WuKu Industrial Park,

Taipei County, Taiwan R.O.C.

Fax: 886-2-22991030 Telephone: 886-2-22991901 http://www.tehlin.com.tw E-mail: tlco@ms2.hinet.net

To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, maximum speed, weight limit, and two seat for the new device. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent.

Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and We believe that FDA can decide the subject device and the only minor differences exist. predicate device are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three bars extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2004

Teh Lin Prosthetic & Orthopaedic, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K042012

Trade/Device Name: Teh Lin Power Scooter TL-822 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 31, 2004 Received: September 7, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the thave been reclassified in accordance with the provisions of the Federal Food, Drug, do noos that have been 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 Tod may, dicrerer, mains of the Act include requirements for annual registration, listing of general voltaren providering 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 If your de rees to such additional controls. Existing major regulations affecting your device can may or babyer to been 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 r 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 or uny i 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) This letter will and w you're begin inding of substantial equivalence of your device to a legally premaired 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 If you desire specific acrios is 301) 594-4659. Also, please note the regulation entitled, Comact the Office of Compuners as (bet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational 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 1

510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: TEH LIN POWER SCOOTER TL-822

INDICATIONS FOR USE:

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

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

510(k) Number K042012

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).