(195 days)
The Opti-Rider Deluxe is a motorized, battery-operated, fourwheel scooter used for transportation by disabled persons.
The proposed Opti-Rider Deluxe consists of a motorized, four-wheeled chassis with batteries, drive unit, steering column, braking system, and electronics module for operational control of the vehicle. The user sits in a seat mounted on the chassis and operates the scooter via hand controls and a console mounted on the steering column.
This document describes the premarket notification for the "Opti-Rider Deluxe," a motorized four-wheeled scooter.
Based on the provided text, there is no mention of acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one would typically expect for a medical AI/software device. Instead, the document discusses substantial equivalence to predicate devices and compliance with existing guidance and standards for motorized vehicles.
Here's a breakdown of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's performance in a quantitative table. Instead, it refers to equivalence with predicate devices and compliance with a guidance document. The 'reported device performance' is described qualitatively as "similar" to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance with FDA's "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles," issued July 6, 1995, and reformatted December 18, 1997. | The Opti-Rider Deluxe was tested to demonstrate conformance with the requirements of this guidance document. |
| Compliance with applicable requirements of ANSI/RESNA W/C Vol. 2 - 1998, Section 21. | The Opti-Rider Deluxe is in compliance with the applicable requirements of this standard. |
| "Similar" performance characteristics to predicate devices (C.T.M. Mobility Scooter HS-686 and Mega 4 Scooter). | "Performance characteristics such as maximum forward and reverse speed, turning radius, maximum safe incline, etc., are similar between the proposed and predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of an AI/software device's performance evaluation. The "testing" mentioned refers to engineering and design verification against a guidance document and standard.
- Sample Size: Not applicable in the context of a clinical test set. The testing would have involved the physical device itself.
- Data Provenance: Not applicable. The testing done was likely in-house engineering and safety testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical motorized scooter, not an AI/software device requiring ground truth established by experts interpreting data. The "ground truth" for its performance would be its actual physical characteristics and safety features.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of typical AI/software performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical device (motorized scooter), not an AI system. Therefore, an MRMC study is irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the context of AI/software. The "ground truth" for this device would be its physical specifications, safety features, and functional performance as measured against engineering standards and guidance.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device.
§ 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).