(448 days)
The device provides transportation for an elderly or disabled person. It can be used in a variety of indoor settings.
The Freerider FR1 is a battery-powered, four-wheeled scooter intended to provide mobility for elderly or disabled individuals in indoor and outdoor settings. The FR1 is meant to be used by a single rider weighing up to 400 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that can be removed for transport or height adjustment.
The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, an emergency brake, and buttons on the tiller console to control movement of the scooter.
The FR1 has a controller and 2 batteries. The controller is used on a number of other scooters that have been previously cleared. There is also an off-board battery charger, which has also been previously cleared. The specifications of battery charger is same as a predicate device, Heartway powered mobility S-12(K092650).
The provided document is a 510(k) premarket notification for the Freerider FR1 motorized three-wheeled vehicle. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and clinical study details (like sample size, ground truth, expert opinions, effect size) is not applicable or available in this document.
Here's the information that can be extracted or deduced from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the way typically seen for diagnostic or AI-driven medical devices. Instead, the "performance" verification for this device is based on compliance with standards and comparison to predicate devices.
| Acceptance Criterion Type | Reported Device Performance / Assessment |
|---|---|
| Safety and Effectiveness | Demonstrated by testing in compliance with national and international standards. No new issues of safety and effectiveness are raised by the differences from predicate devices. |
| Electromagnetic Interference (EMI) | Passed testing to IEC Standards. |
| RESEA (Rehabilitation Engineering and Assistive Technology Society of North America) | Testing to multiple sections of WC-1 and WC-2 was conducted, and the device passed. |
| Ground Current Leakage | Bench testing was conducted, and the device passed. |
| Summary Matrix Testing | Bench testing was conducted, and the device passed. |
| Functional Equivalence | Use parameters are very similar to predicate devices. Slight differences include higher maximum weight capacity and larger turning radius, but these do not raise new safety or effectiveness issues. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. This device is a mobility scooter, and its testing involves engineering and safety standards, not a "test set" of patient data.
- Data Provenance: Not applicable. The testing is based on engineering and performance standards for the physical device.
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 expert consensus is not relevant for a motorized three-wheeled vehicle. Safety and performance are assessed against established engineering standards.
4. Adjudication method for the test set
Not applicable. There is no clinical "test set" requiring adjudication in the context of this device's submission.
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 physical mobility device, not a diagnostic or AI-assisted system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve algorithms or AI in the sense of a standalone diagnostic or assistive system. Its function is direct physical mobility.
7. The type of ground truth used
Not applicable. For this device, "ground truth" is effectively defined by compliance with established national and international safety and performance standards for medical devices and motorized vehicles.
8. The sample size for the training set
Not applicable. This device does not utilize a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, the establishment of its ground truth is irrelevant.
§ 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).