(259 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Wu's 4-Wheeled Neo Scooter, WT-L4
Please Note: The provided text is a 510(k) clearance letter from the FDA for a device called "Wu's 4-Wheeled Neo Scooter, WT-L4." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about specific acceptance criteria studies, performance metrics, or study methodologies that would be found in a clinical trial report or a comprehensive device performance study.
Therefore, the following response will indicate where the requested information is not available in the provided document and will attempt to infer or state general principles where possible.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document. |
| (Typically involves safety, functional performance, durability, etc., for a mobility device) | (Performance data and benchmarks are not detailed in an FDA clearance letter.) |
Explanation: The FDA 510(k) clearance letter confirms substantial equivalence. It does not typically detail the specific acceptance criteria and performance data from validation studies. This information would be found in the 510(k) submission itself, including device testing and performance data submitted by the manufacturer to demonstrate safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
- The manufacturer is "Wu's Tech Company, LTD." from Hsin-Chu City, China (Taiwan). Any testing would likely involve participants or data from that region or other regions where testing was conducted.
- The document does not indicate if data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable and not available in the context of this device.
- This question is typically relevant for AI/ML-driven diagnostic devices where human experts establish ground truth for image or data interpretation.
- For a motorized scooter, "ground truth" would refer to objective performance metrics (e.g., speed, range, stability, braking distance, weight capacity) measured against engineering specifications and industry standards, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
- This information is not applicable and not available in the context of this device.
- Adjudication methods (like 2+1 or 3+1) are primarily used in diagnostic studies involving expert interpretation of medical images or data where discrepancies need to be resolved to establish ground truth.
- For a physical device like a scooter, performance would be assessed through objective measurements and user outcome studies, not through expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done, nor is it relevant for this device.
- MRMC studies are specifically designed for evaluating diagnostic accuracy, particularly with AI assistance in image interpretation, comparing human readers with and without AI.
- This device is a mobility scooter, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone (algorithm only) performance study was not done, nor is it relevant for this device.
- This concept applies to AI algorithms that operate independently to perform a diagnostic or analytical task.
- The Wu's 4-Wheeled Neo Scooter is a physical, user-operated device; it does not involve algorithms in the sense of a standalone diagnostic or analytical tool.
7. The Type of Ground Truth Used:
- Not explicitly stated in the document.
- Inferred Ground Truth: For a motorized three-wheeled vehicle like a scooter, the "ground truth" for demonstrating safety and effectiveness would involve a combination of:
- Engineering specifications and objective measurements: Testing against established standards for stability, braking, speed, range, weight capacity, battery life, turning radius, electromagnetic compatibility, etc.
- Clinical performance/user outcomes: Potentially studies on user comfort, ease of use, maneuverability, and safety in real-world or simulated environments, compared to predicate devices or established benchmarks for mobility.
- Material and component testing: Ensuring all parts meet quality and safety standards.
8. The Sample Size for the Training Set:
- Not applicable and not available in this document.
- A "training set" refers to data used to train an AI/ML algorithm. This device is not an AI/ML algorithm.
- If any user studies were conducted for safety or performance, they would have a "study population" or "test subjects," but this is distinct from a "training set" in the AI context.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable and not available in this document.
- As this is not an AI/ML device, there is no "training set" or ground truth established for it in that context.
§ 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).