(35 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Be-Mobile 3-wheeled Electric Scooter DK S320 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-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 enboard battery charger.
Here's a breakdown of the acceptance criteria and study information for the Be-Mobile 3-wheeled Electric Scooter, DK S320, based on the provided FDA 510(k) summary:
This device is not an AI/ML powered device, therefore, some of the requested information (like multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable and will be marked as N/A.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | Passed |
| CISPR 11: 1990 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement) | Passed |
| EN61000-3-2: 1995 (Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)) | Passed |
| IEC61000-3-3: 1995 (Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low voltage supply systems for equipment with rated current ≤ 16A per phase and not subject to conditional connection) | Passed |
| Substantial Equivalence to Predicate Device (WU`S 3-wheeled NEO SCOOTER WT-L3 (K023040)) | Achieved (Electronic systems are the same and UL certificated, ensuring the same safety level. Differences in controller, overall dimensions, tire size, and weight are noted but deemed not to affect safety.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical trials or data for performance evaluation in the way AI/ML devices typically would. The performance testing refers to engineering standards applied to the device itself.
- Sample Size for Test Set: N/A (Performance testing was conducted on the device, not a distinct "test set" of patient data.)
- Data Provenance: N/A (The testing relates to product compliance with engineering standards, not patient data.)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. Ground truth in this context refers to compliance with established engineering and safety standards, which are verified through defined test procedures. It doesn't involve expert medical interpretation of data.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of medical images or data. For engineering standards, the outcome is pass/fail based on objective measurements against the standard's criteria.
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
N/A. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is compliance with established international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). The "performance testing" section indicates that the device "passed" these standards. Additionally, the basis for clearance is substantial equivalence to an existing legally marketed predicate device (WU`S 3-wheeled NEO SCOOTER WT-L3).
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
N/A. This is not an AI/ML device.
§ 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).