The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

The MOBIE scooter consists of a foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a Li-ion battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be folded for transport in a car trunk. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.

AI/ML Overview

The provided text is a 510(k) summary for the MOBIE scooter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain the specific information required to answer your request regarding acceptance criteria for an AI/device performance study.

The MOBIE scooter is a Class II medical device, specifically an electrical scooter for mobility. The "Summary of non-clinical testing" section indicates compliance with various ISO and ANSI/RESNA standards related to wheelchairs and motorized vehicles. These standards generally cover aspects like safety, durability, stability, electromagnetic compatibility, and biocompatibility, but they are not "acceptance criteria" for an AI performance study, nor do they detail a study where device performance is measured against such criteria.

Here's why the requested information cannot be extracted from this document and what each numbered item from your prompt means in the context of an AI device submission:

A table of acceptance criteria and the reported device performance: This document lists various ISO and ANSI/RESNA standards that the MOBIE scooter complied with. It does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for an AI algorithm) nor does it report the device's performance against such metrics. The compliance statement simply says the device met the requirements of these standards, which are qualitative or quantitative tests for physical and electrical safety/performance, not AI algorithm performance.
Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of evaluating an AI algorithm. The testing described for the MOBIE scooter is hardware-focused, likely involving physical devices undergoing tests dictated by the listed standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is entirely irrelevant for a physical mobility device like the MOBIE scooter. Ground truth established by experts is crucial for AI/ML medical devices where the AI is performing a diagnostic or prognostic task.
Adjudication method: Similar to point 3, this is for AI performance evaluation, not a physical product's safety and performance testing.
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: An MRMC study is designed to evaluate the impact of an AI algorithm on human reader performance for tasks involving interpretation (e.g., radiology images). This is not applicable to a mobility scooter.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: "Standalone" performance refers to an AI algorithm operating independently to produce an output. The MOBIE scooter does not contain an AI algorithm that would have standalone performance in a medical decision-making context.
The type of ground truth used: As mentioned, the concept of "ground truth" as it applies to AI algorithm validation (e.g., pathology, expert consensus) is not pertinent to the evaluation of a physical medical device like this scooter. The "ground truth" for the scooter's performance would be whether it physically meets the engineering and safety specifications of the relevant standards.
The sample size for the training set: This refers to the data used to train an AI algorithm. The MOBIE scooter does not describe any AI component requiring a training set.
How the ground truth for the training set was established: Again, this relates to AI algorithm development, which is not discussed in this document regarding the MOBIE scooter.

In summary, the provided 510(k) pertains to a physical medical device (an electrical scooter) and describes its compliance with established safety and performance standards for such devices. It does not contain any information related to the development or validation of an AI/ML medical device, which would involve acceptance criteria, test sets, ground truth, or expert evaluations as outlined in your prompt.

Summary

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K122749 1/2

Prestige Sporting Goods Co., Ltd.

31d Industry District, Qiaotou Area, Houjie Town, Dongguan City, Guangdong Province, 523950, China TEL: +86-769-85922501 FAX: +86-769-85922505

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: Aug. 20, 2012

Applicant

Name: Prestige Sporting Goods Co., Ltd.

Address: 3rd Industry District, Qiaotou Area, Houjie Town, Dongguan City,

Guangdong Province, 523950, China

Contact person: Mr. Alex Wu, Marketing Director

Phone: +86-769-85922501

Fax: +86-769-85922505

e-mail: alex@solaxtech.com

Device

Trade name: MOBIE scooter

Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: INI

Classification: Class II

Predicate devices

Luggie(K110165) / Freerider Corporation

Intend use of device

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device description:

The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and

DEC 2 7 2012

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Prestige Sporting Goods Co., Ltd.

3td Industry District, Oiaotou Area, Houjie Town. Dongguan City, Guangdong Province, 523950, China TEL: +86-769-85922501 FAX: +86-769-85922505

disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop,

Summary of non-clinical testing

The MOBIE scooter complied with the requirements of ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 7176-21, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10, and ANSI/RESNA WC. Vol. 1 Sec. 7 and Sec 8.

Statement of substantial equivalence

The MOBIE scooter is substantially equivalent to the Luggie(K110165). They have same intended use of a motor driven, indoor and outdoor transportation vehicle to provide mobility to a disabled or elderly person limited to a seated position.

The design and technological characteristics of this device is basically similar to the predicate device chosen. Both are foldable scooters and have the same user interface and self-contained Li-ion battery.

While there are minor differences between the devices, do not alter the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.

Conclusion

In accordance with the Federal Food. Drug and Cosmetic Act. 21 CFR Part 807 and based on the information provided in this premarket notification. Prestige Sporting Goods Co., Ltd. concludes that. MOBIE scooter is substantially equivalent to predicate devices as described herein.

8-2

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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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Prestige Sporting Goods Company, Limited % Mrs. Junnata Chang Director, Regulatory Affairs 16F-2(16A), NO.462, Section 2 ChongDe Road., Beitun District Taichung, China (Taiwan) 406

Re: K122749

Trade/Device Name: MOBIE SCOOTER Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: November 08, 2012 Received: November 08, 2012

Dear Mrs. Chang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

Letter dated: December 27, 2012

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Page 2 -- Mrs. Junnata Chang

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl it Fart 607); adoling (21 CFR 803); good manufacturing practice requirements as set de rice related daverse ovenior (2 regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): _K122749

Device Name: MOBIE SCOOTER

Indications for Use:

The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Over-The-Counter Use_ X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Brian D. Pullin -S

Division of Neurological and Physical Medicine Devices 510(k) Number: K122749 .

(Posted November 13, 2003)

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).