(11 days)
The intended use of the Mega Motion, Inc, Travel Pal Four Wheel 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 Four - Wheel Scooter is a battery-operated compact scooter equipped with a digital controller. Features include an adjustable and removable molded plastic seat, a foldable tiller, one-piece solid frame, and an off board charger, designed for ultimate performance, stability and portability. Additional features include electronic regenerative / electromechanical disc brakes, and rear anti-tip wheels designed for ultimate safety.
The device described is the Travel Pal Four-Wheel Scooter (K080288), manufactured by Mega Motion, Inc.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from compliance with various ANSI/RESNA WC standards. The document states that the device has "passed all the necessary testing procedures," implying that it has met the requirements of each standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/01 Determination of Static Stability | Passed |
| ANSI/RESNA WC/02 Determination of Dynamic Stability | Passed |
| ANSI/RESNA WC/03 Effectiveness of Brakes | Passed |
| ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range | Passed |
| ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space | Passed |
| ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths | Passed |
| ANSI/RESNA WC/09 Climatic Tests | Passed |
| ANSI/RESNA WC/10 Obstacle Climbing | Passed |
| ANSI/RESNA WC/14 Power and Controls | Passed |
| ANSI/RESNA WC/15 Documentation and Labeling | Passed |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility | Passed |
| ANSI/RESNA WC/93 Maximum Overall Dimensions | Passed |
| CAL 117 - Flammability Testing | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for the "non-clinical testing" (the testing against the ANSI/RESNA WC standards). These tests are typically performed on a limited number of production or pre-production units. The data provenance is not specified beyond being "non-clinical testing." It's generally assumed such testing is performed in a controlled laboratory environment. It is implicitly "prospective" as it's done specifically to demonstrate compliance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The concept of "experts establishing ground truth" as it applies to clinical diagnostics or imaging interpretation (like radiologists) is not relevant for this device. The standards themselves define the "ground truth" or the acceptable performance parameters. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standard's specifications. Their qualifications are not specified but would typically involve expertise in mechanical engineering, electronics, and product safety testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex data (e.g., medical images). This is not applicable to the non-clinical testing of a mobility scooter. The "adjudication" is inherent in the pass/fail criteria defined by each specific ANSI/RESNA WC standard.
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
No MRMC comparative effectiveness study was done. This type of study (often used for AI-assisted diagnostic tools) is not relevant to a mobility scooter. The study performed focuses on safety and performance characteristics against established engineering standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical mobility scooter, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims is defined by the ANSI/RESNA WC standards and CAL 117 Flammability Testing. These are widely accepted industry standards that specify test procedures and acceptable performance limits for wheelchairs and scooters.
8. The sample size for the training set
This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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).