(121 days)
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.
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.
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.
§ 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).