The Be-Mobile 3-wheeled Electric Scooter DK S200 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. 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 is a 510(k) summary for the "Be-Mobile 3-wheeled Electric Scooter, DK S200". It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one might for a novel AI/software medical device.

Therefore, many of the requested sections related to AI/software device performance, ground truth, expert adjudication, and MRMC studies are not applicable and cannot be answered from the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device's intended medical purpose (providing mobility). Instead, it focuses on demonstrating safety and functionality equivalence to a predicate device through compliance with specific standards.

Acceptance Criteria (related to safety/standards)	Reported Device Performance
EMC Report ANSI / RESNA WC/Vol.2-1998	"Passed" (Implied by the statement "all passed by the UL certificated" for electronic systems and "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" under "Performance Testing")
CISPR 11: 1990	"Passed" (Implied by the statement "all passed by the UL certificated" for electronic systems and "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" under "Performance Testing")
EN61000-3-2: 1995	"Passed" (Implied by the statement "all passed by the UL certificated" for electronic systems and "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" under "Performance Testing")
IEC61000-3-3: 1995	"Passed" (Implied by the statement "all passed by the UL certificated" for electronic systems and "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" under "Performance Testing")
Resistance ignition test (for back upholstery)	"Passed the resistance ignition test by SGS"
Electronic systems certification	"All passed by the UL certificated" (specifically mentioned for electronic controller, batteries, and recharge)

2. Sample size used for the test set and the data provenance

Not applicable. This device is a physical medical device (electric scooter), not a software/AI device that would typically have a "test set" of data. Performance testing appears to be based on compliance with established engineering and safety standards, likely involving a single device or a small representative sample.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for AI/software pertains to expert labeling of data. For this physical device, "ground truth" would be compliance with engineering standards as verified by testing laboratories (e.g., SGS, UL). The document does not specify the number or qualifications of individuals involved in these testing processes, beyond naming the certifying bodies.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of expert adjudication for 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 not an AI-powered device, and therefore no MRMC study looking at human reader performance improvement is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For safety and functional equivalence:

Compliance with recognized electrical and mechanical standards: EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for general performance and electrical safety.
Safety certifications: UL certification for electronic systems (controller, batteries, recharge).
Material testing: SGS certification for the resistance ignition test of the back upholstery.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set."

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

Not applicable. This is not an AI/machine learning device.

Summary

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TUNG KENG ENTERPRISE No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang ichung County, Taiwan +886-4-25321000 Fax: +886-4-25325000 -mail: dkcity@ms21.hinte.net

દ્ધ 510(k) SUMMARY "

Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

Be-Mobile 3-wheeled Electric Scooter, DK S200 Electrical Scooter Motor Three-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 wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: J.D. 3-wheeled SCOOTER ES-350 (K022518)

September 29, 2003

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UNG KENG ENTERPRISE CO 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang chung County, Taiwan +886-4-25321000 Fax: +886-4-25325000 mail: dkcity@ms21.hinte.net

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also 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 3-wheelled scooters are different overall dimensions, and the dimensions for the new device are smaller than those of the predicate device. Thus the new device needs smaller the overall dimension, weight limit, and the scooter weights are differences between the two devices. The new device, DK S200, of the smaller dimensions can be fitted into most of the ordinary car trunk, and this is NOT related to the safe aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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DEC 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tung Keng Enterprise Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K033240

Trade/Device Name: Be-Mobile 3 Wheeled Electric Scooter, DK S200 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: November 18, 2003 Received: November 25, 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.

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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) 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

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__________________________________________________________________________________________________________________________________________________________________________

510 (K) NUMBER ( IF KNOW ): _ K 033240

DEVICE NAME: Be-Mobile 3-Wheeled Electric Scooter, DK S200

INDICATIONS FOR USE:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over - The - Counter - Use V AND/OR

(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 )

** Restorative Devices

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).