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510(k) Data Aggregation
(30 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S SCOOTER WT-T3H is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled, a seat, two armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
1. Acceptance Criteria and Reported Device Performance
This device (WU'S ELECTRICAL SCOOTER, WT-T3H) is a motorized three-wheeled vehicle. The acceptance criteria and reported device performance are based on comparison to a legally marketed predicate device (WU'S SCOOTER WT-T3D (K032488)) and adherence to relevant performance standards.
| Acceptance Criteria | Reported Device Performance (WT-T3H) |
|---|---|
| Intended Use | Same as predicate: "To provide mobility to persons restricted to a seated position." |
| Weight Limit | 250 lbs (Same as predicate) |
| Maximum Speed | 4 mph (Same as predicate) |
| Safety Climbing Angle | 8° (Same as predicate) |
| Back Upholstery Material | Same as predicate; passed resistance ignition test by SGS (Same safety level) |
| Electronic Systems | Passed UL certification (electronic controller, batteries, recharge) (Same as predicate) |
| EMC Report Standards | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) |
2. Sample Size and Data Provenance
The document does not detail specific sample sizes for a test set in the traditional sense of a clinical or laboratory study with a cohort of subjects. The evaluation is primarily based on:
- Comparison to a predicate device: This involves comparing specifications and performance characteristics.
- Compliance with established engineering standards: These standards represent predefined test methods and acceptable limits.
Therefore, the concept of a "test set" as in clinical data is not directly applicable here. The data provenance is derived from engineering and safety testing performed on the device itself and its components, likely in a controlled laboratory environment. The country of origin for the submitting company is China (Taiwan).
3. Number of Experts and Qualifications
The document does not specify the number or qualifications of "experts" used to establish ground truth for a test set. The ground truth for this type of device is established through:
- Regulatory standards: The expertise is embedded in the development of the ANSI/RESNA, CISPR, EN, and IEC standards.
- Component certifications: UL certification also relies on the expertise of their testing and certification bodies.
- Comparison to the predicate: The predicate device itself has already undergone a regulatory review based on established safety and performance criteria.
4. Adjudication Method
An adjudication method in the context of expert review for a test set is not described or applicable here. The assessment is based on objective measurements against engineering standards and direct comparison of specifications to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not applicable to this type of device. This device is a mobility aid, and its performance is evaluated against engineering specifications and safety standards, not through diagnostic accuracy or interpretation by human readers.
6. Standalone Performance Study
Yes, a standalone performance assessment was done in the sense that the device was subjected to performance testing against established standards (EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). The document states that the electronic systems (controller, batteries, recharge) passed UL certification, indicating testing of these components in isolation.
7. Type of Ground Truth Used
The ground truth used is primarily:
- Engineering Standards: Compliance with recognized national and international standards for electrically powered wheelchairs, scooters, and their chargers.
- Performance Specifications of a Predicate Device: Direct comparison of key performance characteristics (e.g., weight limit, speed, climbing angle) to an already cleared device.
- Component Certifications: Independent certification (UL) for critical electronic components.
8. Sample Size for the Training Set
A "training set" in the context of machine learning or AI is not applicable to this device. This is a physical medical device, not a software algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established
As there is no training set for a machine learning algorithm, this question is not applicable.
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