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