(24 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO 36 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.
This is a 510(k) premarket notification for a Powered Wheelchair, which is a Class II medical device. The information provided describes the performance testing and comparison to a predicate device, as opposed to a study on software or AI performance. Therefore, many of the requested categories (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this type of submission.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria / Test Method | Reported Device Performance (Mambo 36) |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | The device "passed" these tests. Specifically, the electronic systems use "the same suppliers" as the predicate device and "all passed by the UL certificated," assuring the "same safety level." |
| Strength and fatigue tests (for mainframes) | Mainframes of the two devices (Mambo 36 and Mambo 36X) "all meet the strength and fatigue tests". |
| Resistance ignition test (for back upholstery materials) | Back upholstery materials are the "same fabric and passed the resistance ignition test." |
| Cruising range per charge | 20-30 miles (Improved compared to 10-15 miles for predicate device) |
| Incline angle | 8 degrees (Improved compared to 5 degrees for predicate device) |
| Weight capabilities | 130 kgs (Same as predicate device) |
| Maximum speed | 6.4 km/hr (Same as predicate device) |
Notes on "Acceptance Criteria" and "Reported Performance":
For a physical device like a powered wheelchair, the "acceptance criteria" are generally established by the referenced standards (e.g., ANSI/RESNA WC/Vol.2-1998 for performance, CISPR 11 for EMC). The document states that the new device passed these tests or met the requirements, which implies it met the acceptance criteria implicitly defined by those standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This submission is for a physical device and references performance testing against established standards for a single device, not a data-driven study with a test set.
- Data Provenance: Not applicable. The testing appears to be physical testing of the device itself, likely performed in Taiwan where the manufacturer is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth as typically understood in AI/software validation (e.g., expert consensus on medical images) is not relevant for the performance testing of a powered wheelchair. The "ground truth" for a wheelchair's performance is adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication method is mentioned or relevant for this type of device submission.
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 is a submission for a physical medical device, not an AI or software assistant designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical sense. The "ground truth" for this device's performance is compliance with established international and national standards for wheelchair safety and performance (e.g., ANSI/RESNA, CISPR, EN, IEC standards). This is determined through physical testing and measurement.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).