(301 days)
The Mega 3 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 3 scooter 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 3 is a three-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 3-wheel scooter with a sharp turning radius makes it ideal for indoor use and cornering in close quarters. The Mega 3 scooter is also ideal for outdoor use as it is capable of traversing bumpy or uneven terrain.
The Mega 3 is a three-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 3 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion.
The Mega 3 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 in two ways: a throttle lever and a speed potentiometer.
The Mega 3 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 3 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 1/2" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 3 has an adjustable tiller for user comfort and easy transportation.
The Mega 3 scooter has an on board charger as standard equipment. 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.
The Mega 3 uses two 12-Volt 31 Amp sealed lead acid batteries. Certifications from the battery supplier that the batteries used on the Mega 3 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.
The provided text describes a 510(k) application for a power scooter, not a medical device involving AI or complex performance criteria related to diagnostics. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted and a clear indication of what is not present in the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a physical device (a power scooter) and not a diagnostic or AI-driven system, the "acceptance criteria" are implied by the standards it passed and its technical specifications. There isn't a table specifically outlining acceptance criteria in the manner requested for an AI model's performance metrics (e.g., sensitivity, specificity).
| Acceptance Criteria (Implied by Standards/Specifications) | Reported Device Performance |
|---|---|
| Safety: Passed relevant sections of ANSI/RESNA Standard, WC/14, December 1991 | Passed sections 00, 01, 02, 03, 05, and 10 of ANSI/RESNA Standard, WC/14, December 1991 |
| EMI Immunity: (Generally achievable and useful) | Passed at an immunity level of 20 V/m |
| Charger Safety: Minimum voltage ground leakage | Passed |
| Battery Safety/Transportation: Non-spillable | Meets 49CFR173.159(d) and Special Provision A67 of IATA Dangerous Goods Regulations |
| Maximum Forward Speed: | 5.0 mph |
| Maximum Reverse Speed: | 3.0 mph (60% of forward speed) |
| Weight Capacity: | 250 lbs. |
| Maximum Range: | 20-25 miles |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this device. The testing described is for the physical scooter's performance against engineering standards.
- Data Provenance: Not applicable. The testing is reported as nonclinical, laboratory-based performance testing of the device itself.
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)
- Not applicable. The "ground truth" for a power scooter's performance is objective measurement against established engineering standards (e.g., speed, weight capacity, EMI immunity tests). No human expert consensus was needed to establish this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to diagnostic interpretation where disagreements need resolution. For physical device testing, the results are typically directly measured or observed.
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 a power scooter, not a diagnostic system or AI-assisted tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm. Its operation is "standalone" in the sense that it functions independently once operated, but not in the context of an AI algorithm evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth Type: Objective engineering standards and direct measurements. For example, maximum speed is a direct physical measurement, EMI immunity is tested against a defined electromagnetic field.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning model that undergoes "training."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this type of device.
Summary of Relevant Information:
The study conducted was a nonclinical test of the Mega 3 power scooter against the ANSI/RESNA Standard, Wheelchairs – Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05, and 10.
The device passed these tests. Additional nonclinical tests included:
- EMI testing, where it passed at an immunity level of 20 V/m.
- Charger safety for minimum voltage ground leakage, which it passed.
- Battery safety, with certifications confirming compliance with 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries.
No clinical tests were submitted. The conclusions drawn are based on the comparison of design, function, and features to predicate devices and the results of the nonclinical testing against the ANSI/RESNA standards.
§ 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).