(79 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S 4-WHEELED SCOOTER WT-L4Jr is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, 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.
This document describes a mobility scooter, the WU'S 4-Wheeled Scooter, WT-L4Jr, and its substantial equivalence to a predicate device. The information provided does not pertain to an AI/ML powered medical device, therefore, many of the requested criteria are not applicable.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Predicate Device Equivalence | To be substantially equivalent to the legally marketed predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)). This implies similar safety and effectiveness. | The electronic systems between the two devices are the same and UL certified (electronic controller, batteries, recharge). The new device (WT-L4Jr) is more agile and easy to store/transport, while the predicate (WT-L4) is for general use. Differences in overall dimension, tire size, and weight are noted as "not safety aspect." |
| Performance Testing (Safety) | Conformance to relevant safety and performance standards for electrically powered wheelchairs and scooters. | EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 standards were used as references for performance testing. (The report states these were passed, but specific results are not detailed). |
| Indications for Use | Intended for medical purposes to provide mobility to persons restricted to a seated position. | The new device also meets this indication. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a physical mobility scooter, not an AI/ML algorithm that uses a test set of data. The "testing" refers to physical product testing for safety and performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to labels for datasets. For a physical product, "ground truth" would be established through engineering specifications, safety standards, and performance testing, likely conducted by qualified engineers and technicians, not experts establishing diagnostic labels.
4. Adjudication method for the test set
Not applicable. There is no "test set" in the AI/ML sense, and thus no adjudication method for it.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the "ground truth" for safety and performance would be established by:
- Engineering Specifications: Design documents detailing materials, dimensions, electrical components, and mechanical functionality.
- Safety Standards: Compliance with recognized national and international standards for electrically powered mobility devices (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-4-2, IEC61000-4-3).
- Performance Metrics: Measured values for aspects like speed, braking distance, turning radius, battery life, stability, and electromagnetic compatibility.
- Predicate Device Characteristics: The performance and safety profile of the legally marketed predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4) serves as a benchmark for equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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).