(301 days)
The Mega 4 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 4 is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.
The Mega 4 is a four-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 4-wheel scooter with a two wheel front end provides for a very stable ride. The Mega 4 scooter is an ideal outdoor scooter capable of traversing bumpy or uneven terrain. The Mega 4 is a four-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 4 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion. The Mega 4 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated by two devices: a throttle lever and a speed potentiometer. The Mega 4 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 4 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 ¼" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 4 has an adjustable tiller for user comfort and easy transportation. The Mega 4 scooter has an on board charger as standard equipment. The Mega 4 uses two 12-Volt 31 Amp sealed lead acid batteries.
This document is a 510(k) summary for the Mega 4 power scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as typically seen for novel medical devices.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and pathology/outcomes ground truth) are not applicable or not provided in this type of submission.
The "acceptance criteria" here are implied by the standards the device was tested against and the performance compared to the predicate device. The "study" is a non-clinical test report.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Standard) | Reported Device Performance (Mega 4 Scooter) |
|---|---|
| Compliance with ANSI/RESNA Standard WC/14, December 1991 (parts 00, 01, 02, 03, 05, and 10) for Wheelchair - Testing of Power and Control Systems for Electric Wheelchair. | Passed. The Mega 4 power scooter was tested in accordance with the ANSI/RESNA Standard WC/14, December 1991, parts 00, 01, 02, 03, 05, and 10 and passed. The results of these tests are included in section 6 of the 510(k) application package. |
| Electromagnetic Interference (EMI) Immunity Level (e.g., set by standard or internal threshold) | 20 V/m. The Mega 4 has been EMI tested and passed at an immunity level of 20 V/m. (The document notes that "While there is no way to tell if the scooter is totally safe, an immunity level of 20V/m (May '94) is generally achievable and useful.") |
| On-board charger minimum voltage ground leakage requirement (FDA/U.L. Certification) | Passed. The charger has passed the minimum voltage ground leakage as required by the FDA/U.L. Certification from the charger supplier is included in section 4 of the 510(k)-application package. |
| Batteries meeting requirements of 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries (for unrestricted transportation). | Met. Certifications from the battery supplier that the batteries used on the Mega 3 (presumed typo, likely referring to Mega 4) meet the requirements of 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries and are therefore, unrestricted for transportation by any means are enclosed in section 4 of this 510(k)-application package. |
| Substantial Equivalence to Predicate Device (Pace Saver Eclipse Premier) in safety, efficacy, technology, and intended use. | Determined to be substantially equivalent by the FDA. The submission concludes: "Analysis of the comparison of design, function, and features of the Mega 4 power scooter to other devices currently legally marketed for the same intended use, together with the results of testing conducted to access the Mega 4 power scooter's compliance with existing ANSI/RESNA standards for powered wheelchairs demonstrates the Mega 4 to be substantially equivalent to these predicate devices in terms of safety, efficacy, intended use and technology." The FDA's letter concurs with this determination. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated but implies testing was performed on one or more Mega 4 power scooters as part of the non-clinical testing. This is typically a device-level test, not a patient-level study.
- Data Provenance: The tests were conducted by the manufacturer (Mega Motion, Inc.) or a contracted testing facility. The country of origin of the data is not specified but would presumably be where the manufacturing and testing occurred.
- Retrospective or Prospective: These were prospective non-clinical tests performed on the device to demonstrate compliance with standards and for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission details non-clinical device testing against engineering standards, not a clinical study involving experts to establish diagnostic ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This refers to clinical study ground truth establishment, which is not relevant here. The "adjudication" for non-clinical tests would be whether the device passed the specified test criteria as performed by the testing engineers.
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. This is a non-clinical device submission, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes (in principle, for the device as a whole). The non-clinical tests assess the performance of the Mega 4 scooter itself (e.g., EMI, battery safety, power system functionality) without human intervention in the assessment process. It's the device's inherent performance that is being evaluated against the standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was the established engineering standards and regulatory requirements (e.g., ANSI/RESNA WC/14, FDA/U.L. requirements for chargers, battery transport regulations, and the performance characteristics of the predicate device). The device either met these objective criteria or it did not.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; therefore, no training set data would be used.
9. How the ground truth for the training set was established
- Not Applicable. See 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).