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The intended use of the Mega Motion Inc., Travel Pal Powered Scooter, is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers. As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket. The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.

The provided text describes a 510(k) premarket notification for the Travel Pal 3-Wheel Scooter. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a clinical study involving human patients. Therefore, many of the requested categories related to clinical study design (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth for training set) are not applicable in this context.

Here's the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not applicable. The testing described is non-clinical, involving the device itself against engineering standards, not a set of patient data.
• Data provenance: Not applicable. The testing is device-based.

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

• Not applicable. Ground truth, in the context of clinical studies, refers to disease presence/absence or other clinical outcomes. For non-clinical engineering tests, the "ground truth" is defined by the technical specifications of the ANSI/RESNA and CAL standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This pertains to human reader agreement in clinical studies.

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 diagnostic device, and no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm. The device itself underwent performance testing in a standalone fashion against established engineering standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical testing, the "ground truth" is the compliance with the specified engineering and safety standards (ANSI/RESNA WC series and CAL 117). These are objective, measurable criteria.

8. The sample size for the training set:

• Not applicable. There is no AI component or training set involved.

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

• Not applicable. There is no AI component or training set involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Travel Pal 3-Wheel Scooter's acceptance criteria are defined by compliance with a comprehensive set of non-clinical engineering and safety standards. The study proving the device meets these criteria was a series of non-clinical tests performed against the following established standards:

• ANSI/RESNA WC/93: Maximum Overall Dimensions
• ANSI/RESNA WC/01: Determination of Static Stability
• ANSI/RESNA WC/02: Determination of Dynamic Stability
• ANSI/RESNA WC/03: Effectiveness of Brakes
• ANSI/RESNA WC/04: Determination of Energy Consumption - Theoretical Range
• ANSI/RESNA WC/05: Overall Dimensions, Mass & Turning Space
• ANSI/RESNA WC/08: Test methods for Static, Impact and Fatigue Strengths
• ANSI/RESNA WC/09: Climatic Tests
• ANSI/RESNA WC/10: Obstacle Climbing
• ANSI/RESNA WC/15: Documentation and Labeling
• ANSI/RESNA WC Vol. 2-1998 Section 21: Requirements and Test Methods for Electromagnetic Compatibility
• CAL 117: Flammability Testing

The submission states that the Travel Pal "has passed all the necessary testing procedures" and that "Compliance to applicable Testing Standards is as follows: [list of standards]". This indicates that the device's performance was measured against the objective metrics and thresholds established by each of these standards, and in each case, it met the required criteria. The purpose of this testing was to demonstrate substantial equivalence to a predicate device (Mega3, MM-333, K982145) by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness.

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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

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.

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