(40 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 S600 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.
The provided text is a 510(k) summary for a medical device (Be-Mobile 4-Wheeled Electric Scooter, DK S600) seeking substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as an existing one, rather than presenting a performance study against predefined acceptance criteria for a novel medical device.
Therefore, many of the requested elements (like a table of acceptance criteria and reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not detailed in this document.
However, I can extract information related to the performance testing that was conducted to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance & Finding |
|---|---|
| EMC Report: | |
| ANSI / RESNA WC/Vol.2-1998 | The submission states "all passed" by UL certification for electronic systems, implying compliance with safety standards. |
| CISPR 11: 1990 | |
| EN61000-3-2: 1995 | |
| IEC61000-3-3: 1995 | |
| Overall Safety Level (comparative to predicate) | The electronic systems between the two devices are the same and UL certified, ensuring the same safety level. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The performance testing refers to standards (EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). These are likely conducted on a small sample of the device itself (e.g., one or a few units) to verify compliance.
- Data Provenance: The testing was conducted by TUNG KENG Enterprise Co., Ltd. (Taiwan) and confirmed by UL certification in the context of a 510(k) submission. It represents prospective testing of the device for compliance with relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of regulatory submission. The "ground truth" here is compliance with established engineering and safety standards (e.g., EMC, RESNA). Certification bodies like UL (Underwriters Laboratories) are involved in verifying this compliance, but the number and specific qualifications of their individual experts are not detailed in this document.
4. Adjudication method for the test set
- Not applicable. Performance is assessed against quantitative standards, not through expert consensus on qualitative data.
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 an electric scooter, not an AI-enabled diagnostic or assistive system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical and electronic mobility aid, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" used for this device's performance testing is adherence to international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) verified through testing and certification.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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).