The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

Device Description

The American Bantex MS 4 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and two wheel steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 4 breaksdown into several components for easy, tool less assembly, disassembly and transportation.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the American Bantex MS 4 Mini Scooter, seeking substantial equivalence to a predicate device, the Mega Motion, Inc. - Mega 4 Scooter. This document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than establishing de novo acceptance criteria through a clinical study with ground truth. Therefore, many of the requested data points related to a diagnostic device's performance study (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or present in this submission.

However, based on the information provided, we can infer the "acceptance criteria" as the comparable specifications and safety/performance characteristics of the predicate device, and the "study" demonstrating that the MS 4 Mini Scooter meets these criteria is the performance testing and comparison against those specifications.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly the specifications and performance of the predicate device, the Mega Motions, Mega 4 Scooter. The reported device performance is that of the American Bantex MS 4.

Component / Acceptance Criteria (Predicate: Mega Motions, Mega 4)	Reported Device Performance (American Bantex MS 4)	Meets Criteria?
Length: 119 cm	119 cm / 48 inches	Yes
Width: 24 inches	61 cm / 24 inches	Yes
Turning Radius: 42 inches	107 cm / 42 inches	Yes
Maximum Speed: 5 M/h	8 Km/h / 5 M/h	Yes
Weight Capacity: 114 Kgs / 264 Lbs	120 Kgs / 264 Lbs	Yes (exceeds)
Maximum Range: 20-25 Miles	32-40 Km / 17-21 Miles	Yes (comparable/slightly less but within reasonable variation for range)
Battery Type: 2, 12 V 31 AH Lead Acid sealed	2, 12V 32 AH Lead Acid sealed	Yes (comparable)
Brakes: Regenerative and Electromechanical	Regenerative and Electromechanical	Yes
Battery Charger: On-board	On-board, plug in	Yes
Quality Manufacturing System: Conforms to QSR and MDD	Affirmed conformance to QSR and MDD	Yes
Performance Testing: ANSI / RESNA WC/Vol. 2-1998, Section 21	Evaluation and performance verification included testing per ANSI/RESNA WC/Vol. 2-1998, Section 21	Yes
Stability Testing: ISO 7176-1 & -2	Included in submission	Yes
Electrical Immunity Testing: Required by FDA and European Agencies	Included in submission	Yes
Intended Use: Assistance for individuals unable to walk long distances, indoor/outdoor use, requires hand/upper-body mobility	Same indications for use	Yes

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

Sample Size: Not applicable in the context of a 510(k) for a mobility device comparing specifications. The "test set" in this case refers to the single device being submitted (American Bantex MS 4 Mini Scooter) and its performance against predefined standards and the predicate device's specifications. It's not a statistical sample from a larger population for diagnostic accuracy.
Data Provenance: The data comes from the applicant's internal testing and comparison to publicly available specifications of the predicate device. It is retrospective in the sense that the predicate device's data already exists, but the testing on the American Bantex MS 4 would have been conducted prospectively for this submission. The country of origin for the data is not explicitly stated beyond American Bantex Corporation being in California (and later Bountiful, Utah), but the testing methods refer to international standards (ANSI / RESNA, ISO).

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

Number of Experts: Not applicable. There is no "ground truth" expert consensus required for performance characteristics like speed, turning radius, or weight capacity. These are objectively measured specifications. For regulatory compliance and safety testing (e.g., ANSI/RESNA standards), the "experts" would be the accredited testing laboratories and their personnel.
Qualifications of Experts: The document states that testing was done by "Independent Testing Services." The specific qualifications of the personnel at these services are not detailed, but it is implied they are competent to perform testing according to the cited standards.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This type of submission does not involve clinical trial data requiring adjudication of patient outcomes or diagnostic interpretations. The "adjudication" is essentially the FDA's review of the submitted test results and comparison to the predicate device's specifications and relevant standards.

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

Was it done?: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the effect of an AI algorithm on their performance is being evaluated. The American Bantex MS 4 Mini Scooter is a physical mobility device, not a diagnostic tool.

6. Standalone Performance Study:

Was it done?: Yes, in a sense. The "standalone" performance of the American Bantex MS 4 Mini Scooter was evaluated through various engineering and safety tests. The document states: "The evaluation and performance verification included performance testing in accordance with ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. The results of such testing as well as, certifications from upholstery testing, functional performance testing, stability (ISO 7176-1 & -2) and electrical immunity testing required by the FDA and European Agencies are included in this submission." This demonstrates the device's inherent performance characteristics.

7. Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" in this context refers to established engineering specifications, safety standards (like ANSI/RESNA, ISO), and the published specifications of the legally marketed predicate device. There is no pathology, expert consensus, or outcomes data used as ground truth for this type of device comparison.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This refers to AI/machine learning models. The American Bantex MS 4 Mini Scooter is a mechanical and electrical device, not an AI-driven algorithm, so there is no training set in this context.

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

How Established: Not applicable, as there is no training set for this type of device.

Summary

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K040754

JUL 2 3 2004

AMERICAN BANTEX CORPORATION

1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 10, 2004

Summary of Safety and Effectiveness for the:

Trade Name:	American Bantex MS 4, Mini Scooter
Common Name:	Scooter, 4-wheeled, Powered
Classification Number & Name:	89 INI (890.3800) Vehicle, Motorized 3-Wheeled

Legally Marketed Predicate Devices for Substantial Equivalence:

*Mega Motion, Inc. - Mega 4 Scooter, K982144

Rationale for SE: The Mega Motion, Mega 4 is a Class II device that is intended to provide assistance and help people lead a more productive and mobile lifestyle. The 4-wheeled scooter provides a stable ride while the two forward wheels steer the scooter. Mega 4 us an outdoor and indoor product that is capable of traveling on bumpy or uneven terrain. The pneumatic tires and sealed transaxle contribute to the quiet operation of the scooter. The Mega 4 has a built-in charger that plugs into a standard 110-120V~ outlet. The dynamic regenerative brake (electric motor) and secondary parking brake are redundant to one another.

Description of Submitted Device:

American Bantex affirms that we contract with a fully operational quality manufacturing system, which conforms to the QSR requirements of 21 CFR Part 820, as well as the Quality elements of the European Medical Device Directive, 93/42/EEC for CE Marking. Design History Files are maintained for the development and distribution of products and they are tested using Independent Testing Services prior to marketing them.

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Intended Uses of the American Bantex MS 4:

The American Bantex 4 wheeled, MS4 Mini Scooter, has been designed to help people who have a difficult time walking. The user must have use of hand and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS4 Mini scooter is designed for both indoor and outdoor use in clean and dry conditions.

Technological Characteristics and Substantial Equivalence:

Component:	American Bantex MS 4	Mega Motions, Mega 4
Length	119 cm / 48 inches	119 cm
Width	61 cm / 24 inches	24 inches
Turning Radius	107 cm / 42 inches	42 inches
Maximum Speed	8 Km/h / 5 M/h	5 M/h
Weight Capacity	120 Kgs / 264 Lbs	114 Kgs / 264 Lbs
Maximum Range	32-40 Km / 17-21 Miles	20-25 Miles
Battery Type	2, 12V 32 AH Lead Acid sealed	2, 12 V 31 AH Lead Acid sealed
Brakes	Regenerative andElectromechanical	Regenerative andElectromechanical
Battery Charger	On-board, plug in	On-board
510(k) File Number	Pending this Application	K982144

Table 1: Comparison of American Banter, MS 4, to the predicate, Mega Motions, Mega A Scenter

The characteristics, methods of operation, accessories and indication for use are all equivalent to that of the predicate device. The evaluation and performance verification included performance testing in accordance with ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. The results of such testing as well as, certifications from upholstery testing, functional performance testing, stability (ISO 7176-1 & -2) and electrical immunity testing required by the FDA and European Agencies are included in this submission. The battery charger provided is non-medical grade, for home use only.

Conclusion:

The successful testing and comparison has demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Mr. Tracy S. Best American Bantex Corporation 994 North Main St. Bountiful, Utah 84010

Re: K040754

Trade/Device Name: MS 4 Mini Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Codes: INI Dated: July 10, 2004 Received: July 13, 2004

Dear Mr. Best:

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 – Mr. Tracy S. Best

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 premated 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 Marufacturers, 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 N. Milken

Celia M. Witten, PhD, MD 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: MS 4 Mini Scooter

Indications for Use:

The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility.

People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter.

The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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. and Neurological Devices

510(k) Number K040754

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).