(76 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Be-Mobile 4-Wheeled Electric Scooter DK S280 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. 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 looks like a 510(k) premarket notification for a medical device, which is a regulatory submission to the FDA. It's not a study report designed to "prove" a device meets acceptance criteria in the way a clinical trial or performance study would. Rather, it aims to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested elements about statistical sample sizes, expert adjudication, MRMC studies, and standalone performance metrics are not typically part of a 510(k) submission of this nature. The "performance testing" section refers to engineering standards met by the device, not a human reader or algorithm performance study.
Here's an attempt to answer as much as possible based on the provided text, acknowledging the limitations inherent in a 510(k) submission for an electric scooter:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission, the "acceptance criteria" are demonstrating compliance with relevant engineering standards and showing substantial equivalence to a predicate device. The performance isn't about diagnostic accuracy or clinical outcomes in the same way as a medical imaging AI, but rather about safety and functionality.
| Acceptance Criterion (Compliance Standard) | Reported Device Performance |
|---|---|
| EMC Report | Complied with CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 |
| Safety and Performance for Electric Wheelchairs/Scooters | Complied with ANSI / RESNA WC/Vol.2-1998 |
| Electrical System Certification | "The electronic systems between two devices are the same and all passed by the UL certificated" |
| Substantial Equivalence (General) | Determined to be substantially equivalent to WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an "algorithm test set." The testing appears to be on a single device or a small sample to confirm engineering compliance.
- Data Provenance: The device manufacturer, TUNG KENG ENTERPRISE CO., LTD., is located in Taichung County, Taiwan. The specific engineering tests would have been performed by testing bodies or the manufacturer in compliance with the referenced standards. The data is prospective for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth in this context refers to the successful completion of engineering tests according to established standards. The "experts" would be the engineers and technicians performing and verifying compliance with the specified standards (e.g., ANSI / RESNA WC/Vol.2-1998, EMC standards), but they are not establishing a "ground truth" for a diagnostic outcome.
- Qualifications: As above, these would be qualified engineers and testers knowledgeable in the relevant standards.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study requiring human adjudication for diagnostic outcomes. Compliance with engineering standards is typically determined by measurement against predefined thresholds.
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 diagnostic devices (e.g., AI for medical image analysis) to assess improvement in human reader performance with AI assistance. An electric scooter does not have human "readers" or "cases" in this sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study as typically understood for an algorithm was not done. The device's "standalone" performance is assessed by its compliance with engineering standards (e.g., EMC, safety, and performance for electric wheelchairs/scooters) without a human operator performing a diagnostic task. The document details these compliance tests rather than algorithm-specific performance metrics.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is compliance with established engineering and safety standards. This is demonstrated through measurement and testing against predefined criteria within the standards (e.g., electrical interference levels, stability, charger performance). It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This device is an electric scooter, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
§ 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).