(39 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO 36X 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.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the WU's POWERED WHEELCHAIR, MAMBO 36X. This document focuses on establishing substantial equivalence to a legally marketed predicate device, the TEH LIN JUPITER Powered Wheelchair TL-320 (K022697), rather than detailing acceptance criteria and performance data from a specific study designed to "prove the device meets acceptance criteria" in the way one might expect for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth details, training set size) are not applicable or cannot be extracted directly from this type of regulatory submission for a powered wheelchair.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:
Acceptance Criteria and Study for WU's POWERED WHEELCHAIR, MAMBO 36X
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a de novo approval or clinical trial for a novel device. Therefore, the "acceptance criteria" are largely based on meeting established standards and demonstrating similarity in safety and performance to the predicate device. The "study" referenced is the performance testing against these standards, which are not designed to measure metrics like sensitivity, specificity, or accuracy (which are common for AI/SaMD devices).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criterion | Reported Device Performance/Comparison to Predicate |
|---|---|---|
| Intended Use | Same as predicate device. | The intended use between the two devices is the same: "to provide mobility to persons restricted to a seated position." |
| Design/Structure | Mainframes are foldable, similar materials, same suspension (cross brace). | Mainframes of both devices are foldable. Mainframe materials "all meet the strength and fatigue tests and they are similar for the material aspects." The suspension of the cross brace is the same. |
| Components | Same type of armrest, same back upholstery material, same electronic systems. | The two devices used the same type of armrest. Back upholstery material is the same fabric. Electronic systems (controller, batteries, charger) are from the "same suppliers" and "all passed by the UL certificated." |
| Safety (Electrical/Mechanical) | Complies with relevant electrical safety and wheelchair performance standards. | Demonstrated through compliance with: |
- EMC Report ANSI / RESNA WC/Vol.2-1998: Standard for electrically powered wheelchairs, scooters, and their chargers - requirements and test methods.
- CISPR 11: 1990: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement.
- EN61000-3-2: 1995: Limits for harmonic current emissions.
- IEC61000-3-3: 1995: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems.
- Electronic systems are UL certified. |
| Minor Differences (Not impacting safety) | Differences in overall dimensions, seat size, weight limit, speed, range, incline. | The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees. The overall appearance differences are "not safety aspect" and do not affect substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) for a powered wheelchair. Performance testing refers to engineering and electrical safety standards applied to the device itself (e.g., a sample unit of the wheelchair), not a patient-based test set or data set in the manner of AI/SaMD.
- Data Provenance: Not applicable. The "data" here are test results from engineering and electrical safety evaluations of the device's physical and electrical characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. Ground truth, in the AI/SaMD context, refers to a definitively correct label or outcome for a medical condition. For a powered wheelchair, "ground truth" relates to compliance with engineering standards, which is assessed through standardized testing and certification by notified bodies (e.g., UL, and compliance to standards like ANSI/RESNA).
4. Adjudication Method for the Test Set
- Not applicable. This concept is relevant for reconciling discrepancies in expert opinions on medical data, which is not part of 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 powered wheelchair, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not involve a standalone algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Not applicable in the typical medical imaging/AI sense. The "ground truth" for this device is based on established engineering and electrical safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC) as assessed through physical and electrical performance tests. Successful passing of these tests serves as the "truth" that the device meets the safety and performance requirements.
8. The Sample Size for the Training Set
- Not applicable. This device does not employ machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).