(78 days)
The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
The American Bantex MS 3 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 single wheeled 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 3 breaks-down 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 3 Mini Scooter, which is compared to a legally marketed predicate device, the Mega Motion Mega 3 Scooter. The document focuses on demonstrating substantial equivalence rather than presenting an independent study with detailed acceptance criteria and performance data as typically found in clinical trials for new medical devices.
Therefore, many of the requested elements for a detailed study description are not available in this type of submission. However, I will extract what is present.
Acceptance Criteria and Device Performance
The "Acceptance Criteria" for this submission are implicitly tied to demonstrating Substantial Equivalence (SE) to a predicate device. The performance tests conducted are to ensure the new device functions comparably to the predicate and meets basic safety requirements. The document does not list specific quantitative acceptance criteria values for each parameter, but rather states that "The EUT meets the requirements".
Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Running Speed Test | Max speed should be comparable to intended use and predicate device. | "The EUT meets the requirements, There was no performance degradation detected during this test." Max speed data was found. |
| Brake Test | Braking distance should be safe and within expected limits. | "The EUT meets the requirements, There was no performance degradation detected during this test." Braking distance was measured. |
| Acceleration & Deceleration | Rates should be smooth and safe for user operation. | "The EUT meets the requirements, There was no performance degradation detected during this test." Data was calculated using A=V/T. |
Additional Information Not Present in the Document:
Given the nature of a 510(k) summary, specific details regarding sample size, expert involvement, and ground truth establishment, as typically seen in clinical studies for novel devices, are not provided. The submission focuses on device description, comparison to a predicate, and basic functional testing to ensure safety and effectiveness.
- Sample Size for Test Set and Data Provenance: Not specified. The tests described are functional tests performed on "the EUT" (Equipment Under Test), implying a single device or a small sample for engineering verification rather than a large-scale clinical test set. The provenance is internal testing by American Bantex or a contract testing service.
- Number of Experts and Qualifications: Not specified. The testing described appears to be engineering/performance testing, not involving clinical expert assessment in the way envisioned by this question.
- Adjudication Method: Not applicable/specified for these engineering tests.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not performed. The device is a mobility scooter, not an imaging or diagnostic device that would typically involve MRMC studies.
- Standalone Performance: A standalone performance test was performed in the sense that the device was tested as an algorithm-only without human-in-the-loop, though the "algorithm" here is the mechanical and electrical function of the scooter, not a software algorithm. The "RESULTS" section states, "The EUT meets the requirements, There was no performance degradation detected during this test."
- Type of Ground Truth: Not explicitly stated as "ground truth" in a clinical sense. The "ground truth" for these engineering tests are industry standards for scooter performance and the functional specifications expected for such a device, implicitly benchmarked against the predicate device.
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of Device and Rationale for Substantial Equivalence:
The American Bantex MS 3 Mini Scooter is a Class II, three-wheeled motorized scooter intended to assist individuals unable to walk long distances. It is deemed substantially equivalent to the Mega Motion, Inc. - Mega 3 Scooter (K982145) based on similarities in safety, efficacy, technology, and intended use. Both devices are designed for mobility assistance, operate on a 24V system, have sealed transaxle motors, and can be disassembled for transport. The submitter affirms compliance with 21 CFR Part 820 (Quality System Regulation) and European Medical Device Directive 93/42/EEC. Design History Files are maintained, and products are tested using independent testing services.
§ 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).