(101 days)
The LANDLEX S400X 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 S400X 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 S400X 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, automatic headlight 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 9 km/hr (5.6 mph).
Here's a breakdown of the acceptance criteria and the study information for the LANDLEX S400X scooter, based on the provided 510(k) summary:
This device is not an AI/ML powered device, therefore some of the requested information (like MRMC studies, training set, etc.) does not apply.
Acceptance Criteria and Device Performance for LANDLEX S400X Scooter
The LANDLEX S400X scooter demonstrates substantial equivalence to its predicate device, the Bewell SC 20 (K043326), by meeting established performance and safety standards for wheelchairs and motorized scooters. The acceptance criteria are largely defined by compliance with a set of international and national standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Stability | ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 Determination of static stability | Tested to and complies with this standard. |
| Speed, Acceleration, Deceleration | ANSI/RESNA WC/Vol.1 section 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair | Tested to and complies with this standard. (Maximum speed up to 9 km/hr / 5.6 mph explicitly stated in device description, reinforcing compliance with relevant speed determination). |
| Structural Integrity & Durability | ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods | Tested to and complies with this standard. |
| Electromagnetic Compatibility (EMC) | 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 and complies with this standard. |
| CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement | Tested to and complies with this standard. | |
| IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD) | Tested to and complies with this standard. | |
| IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test | Tested to and complies with this standard. | |
| Flammability | California Bureau of Home Furnishings 116 Flammability Standards | Tested to and complies with this standard. |
| Intended Use | Provide mobility to disabled or elderly persons limited to a seated position, capable of 135 kg (300 lbs) weight capacity. | Device description explicitly states intended use and weight capacity, implying performance at this capacity. Compliance with relevant standards (e.g., structural strength) supports this claim. |
| Substantial Equivalence | Demonstrated equivalence to Bewell SC 20 (K043326) in design, function, and features. | Analysis of comparison of design, function and feature of LANDLEX S400X scooter to CHC Bewell SC 20 (K043326), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of individual devices tested, but rather indicates that the LANDLEX S400X scooter "has been tested" to the listed wheelchair standards. It is implied that at least one functional unit of the commercial device was subjected to the full battery of tests for each standard.
- Data Provenance: The testing was non-clinical, meaning it was conducted in a laboratory or test facility setting to confirm compliance with engineering and safety standards. The manufacturer is Besteam Technology Inc. in Taiwan. The testing would have been conducted by or on behalf of the manufacturer, presumably in Taiwan or a recognized testing laboratory. This is a form of prospective engineering testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable to this type of device and study. The "ground truth" for the test set is defined by the technical specifications and performance limits set forth in the international and national standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, California Flammability Standards). Compliance is determined by objective measurements against these predefined thresholds, not by expert consensus on specific cases.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop evaluations where there's subjective interpretation or a need for consensus on expert opinions. For non-clinical engineering testing against established standards, the results are objectively measured and compared to the standard's criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The LANDLEX S400X is a motorized scooter, and its evaluation focuses on engineering performance and safety standards, not diagnostic accuracy or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the LANDLEX S400X is a physical motorized scooter, not an algorithm or AI system. Its "performance" is its mechanical and electrical function and its adherence to safety standards, not an algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily compliance with established engineering and safety standards. These standards define measurable performance criteria (e.g., static stability angles, maximum speed, electromagnetic emission limits, material flammability). The tests performed against these standards provide objective evidence of device performance.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (electric scooter), not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of 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).