(24 days)
The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The LANDLEX S300X scooter is with a 135 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a auto light sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 8 km/hr (5 mph).
This document describes the LANDLEX S300X scooter, a motorized three-wheeled vehicle intended for disabled or elderly persons. The summary indicates that the device was deemed substantially equivalent to a predicate device based on compliance testing to existing ANSI/RESNA, ISO 7176, IEC standards, and California Bureau of Home Furnishings standards.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 | |
| Determination of static stability | "tested to wheelchair standards" - implies compliance achieved |
| ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 | |
| Determination of max speed, acceleration and deceleration of electric wheelchair | "tested to wheelchair standards" - implies compliance achieved |
| ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 | |
| Static, impact and fatigue strengths-Requirements and test methods | "tested to wheelchair standards" - implies compliance achieved |
| ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 | |
| Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters | "tested to wheelchair standards" - implies compliance achieved |
| CISPR 11-1990 | |
| Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement | "tested to wheelchair standards" - implies compliance achieved |
| IEC 61000-4-2-1995 | |
| EMC-Electrostatic discharge immunity test (ESD) | "tested to wheelchair standards" - implies compliance achieved |
| IEC 61000-4-3-1995 | |
| EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test | "tested to wheelchair standards" - implies compliance achieved |
| California Bureau of Home Furnishings 116 | |
| Flammability Standards | "tested to wheelchair standards" - implies compliance achieved |
Note: The document states that the device has been "tested to wheelchair standards" and that these tests "demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended." It does not provide specific numerical results or detailed performance metrics from these tests, only that compliance was achieved.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set (i.e., the number of devices or components tested). It also does not mention the country of origin of the data explicitly, but the manufacturer is based in Taiwan (Besteam Technology Inc., Taoyuan Hsien, Taiwan). The nature of these tests (compliance to standards) implies they were performed prospectively as part of the device development and validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing described is non-clinical performance and safety testing against established industrial and medical device standards (e.g., ISO, ANSI/RESNA, IEC). Ground truth in this context is defined by the objective pass/fail criteria of these standards, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation (e.g., medical imaging reads). For engineering compliance testing, the results are typically objectively measured against predetermined specifications in the standards.
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
There is no MRMC comparative effectiveness study mentioned in this document. This device is a mobility scooter, not an AI-assisted diagnostic or therapeutic tool for which such studies would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical mobility device, not an algorithm, so a "standalone" or "algorithm-only" performance evaluation is not relevant.
7. The Type of Ground Truth Used
The ground truth used for these tests is the objective pass/fail criteria specified by the referenced international and national standards (ANSI/RESNA, ISO 7176, IEC, CISPR, California Bureau of Home Furnishings standards). These standards define acceptable levels of static stability, speed, acceleration, deceleration, strength, EMC, and flammability.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device. The development and testing revolve around engineering design, manufacturing, and compliance with established performance standards for physical products, not machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this 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).