(93 days)
The "eFOLDI Scooter, Lite" is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The eFoldi Scooter. Lite is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with metal alloy frame, one front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable Lithium-Ion Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road or slopes less than 6 degrees. The scooter is foldable.
This document describes the regulatory approval for the eFOLDi Scooter, Lite, a motorized three-wheeled vehicle. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI device or diagnostic.
Therefore, many of the requested items (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment for AI models) are not applicable to this type of regulatory submission for a physical medical device like an electric scooter. The "acceptance criteria" here are defined by compliance with recognized standards and a comparison against a predicate device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Predicate Comparison):
The acceptance criteria for this device are primarily demonstrated through compliance with recognized international standards (ISO 7176 series for wheelchairs and scooters, ISO 10993-1 for biocompatibility, and ISO 7176-21 for EMC) and by showing that any differences from the predicate device do not raise new safety or effectiveness concerns.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance / Compliance |
|---|---|---|
| Safety Standards Compliance | Non-Clinical Tests: Compliance with various ISO 7176 standards, ISO 10993-1, ISO 7176-21 for EMC. This serves as acceptance criteria indicating the device's safety. | Non-clinical tests were conducted and met all design specifications and comply with the following standards: |
- Biocompatibility: ISO10993-1 requirements met for all user-contacting materials.
- EMC: ISO7176-21 compliant.
- Performance (General Safety & Functionality):
- ISO 7176-1 (Static stability) compliant.
- ISO 7176-2 (Dynamic stability of electrically powered wheelchairs) compliant.
- ISO 7176-3 (Effectiveness of brakes) compliant.
- ISO 7176-4 (Energy consumption/range) compliant.
- ISO 7176-5 (Overall dimensions, mass, maneuvering space) compliant.
- ISO 7176-6 (Max speed, acceleration, deceleration) compliant.
- ISO 7176-7 (Seating and wheel dimensions) compliant.
- ISO 7176-8 (Static, impact, fatigue strengths) compliant.
- ISO 7176-9 (Climatic tests) compliant.
- ISO 7176-10 (Obstacle-climbing ability) compliant.
- ISO 7176-14 (Power and control systems) compliant.
- ISO 7176-16 (Resistance to ignition of postural support devices) compliant.
Specific Performance Parameters (compared to predicate):
- Minimum braking distance and time: 0.7 meter for 6km/h speed,
§ 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).