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510(k) Data Aggregation
(66 days)
WU'S 4-WHEELED NEO SCOOTER, WT-XL4
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S 4-WHEELED SCOOTER WT-XL 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.
The provided text describes a 510(k) premarket notification for a medical device, the WU'S 4-WHEELED NEO SCOOTER, WT-XL4. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria in the way one might for a novel AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this submission. The "study" here is primarily a comparison between the new device and a predicate device based on design specifications and compliance with relevant standards.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device type (a durable medical equipment like a scooter), "acceptance criteria" are generally related to compliance with recognized standards and demonstrating that the new device's performance characteristics are at least as safe and effective as the predicate, especially for its intended use.
| Acceptance Criteria (Inferred from 510(k) summary) | Reported Device Performance (WU'S 4-WHEELED NEO SCOOTER, WT-XL4) |
|---|---|
| Intended Use: Provide mobility to persons restricted to a seated position. | Met: Stated as the intended use, identical to the predicate. No deviation from indications. |
| Safety and Electrical Standards Compliance: (e.g., EMC, electrical safety) | Met: Performance testing conducted against ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 standards. Electronic systems (controller, batteries, switching power supplier, excluding recharger) are from the same UL-certified suppliers as the predicate, ensuring "the same safety level." |
| Functional Equivalence: Similar basic operation and components. | Met: Similar batteries, cruising range, back upholstery, armrest types, and warranty period as the predicate. Hand controls for movement. |
| Weight Capacity: Must safely support intended user population. | Met: Designed for patients up to 550 lbs, an increase from the predicate's 300 lbs. This is a differentiating factor, but not a failure to meet a standard; rather, it's an expanded capability. |
| Physical Dimensions/Weight: Appropriate for safe operation and transport. | Met: Overall dimensions, tire size, and weights are different due to the larger weight capacity. These differences are deemed "not safety aspect" and are acceptable for substantial equivalence. |
| Disassembly for Transport: Should be a feature if claimed. | Met: Device can be disassembled for transport. |
| Battery Charging: Proper and safe charging mechanism. | Met: Provided with an onboard battery charger. The recharger supplier differs from the predicate, but this is noted in the context of overall electronic systems being safe. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a clinical study involving human subjects or a dataset for AI. The "test set" in this context refers to the physical device itself undergoing engineering and safety testing.
- Data Provenance: Not applicable. The "data" are primarily design specifications, component certifications (UL), and engineering test reports from the manufacturer (WU'S TECH CO., LTD. in Hsin Chu City, China (Taiwan)).
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/diagnostic devices typically refers to definitive diagnoses or classifications from medical experts. For a physical device like a scooter, the "ground truth" is defined by compliance with engineering standards and the device's physical performance characteristics as determined by engineering tests.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a diagnosis. This procedure is irrelevant to the engineering and safety testing of a scooter.
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 device is a mobility scooter, not an AI or diagnostic tool that assists human readers in interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical, user-operated scooter, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Specifications: The "ground truth" for this submission is established by the relevant engineering and safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC) that the device must comply with, and the functional specifications demonstrated through physical testing and component certifications (e.g., UL certification for electronic components). The predicate device's proven safety and effectiveness also serve as a benchmark.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI training set, this question is irrelevant.
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