The TEH LIN Powered Scooter, TL-560 is an indoor / outdoor Powered Scooter that It has a base with four-wheeled with a seat. is battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.

AI/ML Overview

The provided document is a 510(k) summary for the TEH LIN Power Scooter, TL-560. It focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can provide the information that is available and explicitly state what is not.

Acceptance Criteria and Device Performance Study for TEH LIN Power Scooter, TL-560

This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-821, K042011) rather than presenting a performance study against explicit acceptance criteria. The "Performance Testing" section refers to compliance with specific standards, which serve as the implicit acceptance criteria for safety and electrical compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
EMC Report ANSI / RESNA WC/Vol.2-1998	No specific performance data provided, but implied compliance for equivalence.
CISPR 11: 1990	No specific performance data provided, but implied compliance for equivalence.
EN61000-3-2: 1995	No specific performance data provided, but implied compliance for equivalence.
IEC61000-3-3: 1995	No specific performance data provided, but implied compliance for equivalence.

Note: The document states that the new device and the predicate device "have the same intended use, the same technological aspects and only minor differences exist. So the new device is substantially equivalent to the predicate devices in this aspect." This is the primary "performance" being demonstrated for regulatory purposes – equivalence to a device already deemed safe and effective. The safety level is assured because key components and characteristics (batteries, control systems, recharger, material resistance ignition tests) are the same or have passed relevant tests.

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

This document does not describe a performance study with a specific "test set" in the context of clinical or diagnostic performance. The "performance testing" mentioned refers to compliance with established engineering and electrical safety standards. Therefore:

Sample size for the test set: Not applicable in the context of clinical/diagnostic performance. The tests would be performed on the device itself.
Data provenance (country of origin, retrospective/prospective): Not applicable for the type of testing described (product standard compliance). The resistance ignition test was performed by "SGS," a global inspection, verification, testing, and certification company.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document does not describe a study involving expert assessment or ground truth establishment for a clinical or diagnostic outcome.

4. Adjudication Method

This information is not applicable. No adjudication method is described as there is no clinical or diagnostic study involving multiple readers/assessors.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance or comparison of human readers with vs. without AI assistance. The device is a powered scooter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI is not applicable or described. The performance testing refers to the device's compliance with engineering and electrical safety standards.

7. Type of Ground Truth Used

This information is not applicable in the typical sense for clinical/diagnostic devices. The "ground truth" for the performance testing mentioned (EMC, CISPR, EN, IEC standards) is the state-of-the-art engineering and safety requirements defined by those standards. For material properties, the ground truth is established by passing specific resistance ignition tests (by SGS).

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable as there is no training set for an AI/machine learning device.

Summary

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KOSIII 6

TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

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

MAY 3 1 2005

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

510(k) SUMMARY " દ દ

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

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

April 25, 2005

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

TEH LIN Power Scooter, TL-560 Powered Scooter Powered Scooter, 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 Scooters, controller, and their chargers requirements and test methods)

Legally marketed device for substantial equivalence comparison:

TEH LIN POWER SCOOTER TL-821 (K042011)

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TEH LIN PROSTHETIC & OF

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

Summary for substantial equivalence comparison:

The intended use between the two devices is the same. The batteries used are the same brand that is certified by UL. The control systems for the two devices are same brand i.e., Penny & Giles EGIS type for the two devices. The recharge for the two devices are used the same resource, and the recharge is certified by UL. Besides, the foldable frame, the maximum speed, removable arm type, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS.

Thus the same safety level for the two devices is assured. The major differences existing of the two Power Scooters are the different overall dimension, tires, seat size, weight limit, weight capabilities, safe climbing angle, and cruising range between the two devices. 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 only minor differences exist. So 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.

Public Health Service

MAY 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051116

Trade/Device Name: TEH LIN Power Scooter, TL-560 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle -Regulatory Class: II Product Code: INI Dated: April 25, 2005 Received: May 2, 2005

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been mind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer of the have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been rout 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 , mere over in 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 r read o o a roude a determination that your device complies with other requirements of the Act that I Drederal 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 Of N Fart 677, huolity 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 this letter will anow you to begin maniesing your and equivalence of your device to a legally premiter notification: "The 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 advice for your ac (240) 276-0120 . Also, please note the regulation entitled, colliation of Compulance in (21 the Part 807.97). You may obtain Misolanding by reference to premains. Fibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. Acting 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: TEH LIN Power Scooter, TL-560_

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 __ V

(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)

Styet Rhodes

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

Page 1 _of _1

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).