(10 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO 2 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 510(k) submission (K052559) for the WU'S POWERED WHEELCHAIR, MAMBO 2, is a premarket notification where substantial equivalence to a predicate device is claimed. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics (like accuracy, sensitivity, specificity, etc.) for AI/imaging devices is not directly applicable here.
Instead, the acceptance criteria are generally related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved through comparing technical characteristics, materials, and compliance with recognized standards.
Here's a breakdown of the requested information based on the provided text, adapted to the context of a medical device submission focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (MAMBO 2) |
|---|---|
| Intended Use: Device provides mobility to persons restricted to a seated position. | The device is intended for medical purposes to provide mobility to persons restricted to a seated position. |
| Material Strength and Fatigue: Mainframes meet strength and fatigue tests. | Mainframes materials meet the strength and fatigue tests. |
| Overall Dimensions: Similar to predicate. | Overall dimensions are similar. (Minor differences exist, but not affecting safety). |
| Armrest Type: Same as predicate. | Used the same type of armrest. |
| Weight Limit: Same as predicate. | Same weight limit. |
| Back Upholstery Material: Same fabric as predicate. | Back upholstery material is also the same fabric. |
| Critical Electrical Components Certification (Recharger, Batteries): Certified by UL. | Recharger, batteries, and other critical electrical components are certified by UL. |
| Safety Aspects (Operator Safety): Substantially equivalent. | For the operator's safety aspect they are substantially equivalent. |
| Braking Time, Distance, Dynamic Stability: Meets relevant requirements (supported by lower maximum speed). | Lower speed (3.5 mph for new device vs. 4.0 mph for predicate) means the new device shall more easily to meet the relevant requirements for the braking time, distance, and dynamic stability for safety considerations. |
| Control System Safety and Performance: Assured and validated, substantially equivalent. | Control systems (Penny & Giles for new; Dynamic DL for predicate) are all FDA-clearance. The safety and performance functions of two systems are assured and validated. They are substantially equivalent. |
| Cruising Range (Real-life use): Substantially equivalent despite numerical difference. | Maximum range per charge is 16 km for the new device, and 40 km for the predicate device. For the real life use, the two devices are substantially equivalent. (Acknowledges environmental factors influence real range). |
| Agility and Foldability: New device "more agile and easy to fold for storage or transportation." (Not a direct "criterion" but a key differentiating feature that does not negatively impact safety/effectiveness). | The major difference existing for new device is more agile and easy to fold for storage or transportation. |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a "test set" in the context of clinical data for performance evaluation as would be seen for an AI/imaging device. The assessment is based on a comparison of device specifications, materials, and compliance with recognized standards, primarily through engineering testing and documentation.
- Sample Size: Not applicable in the conventional sense of a clinical test set. The "samples" are the devices themselves undergoing physical and electrical testing.
- Data Provenance: The information is derived from internal design specifications, material certifications (e.g., UL), and engineering test results (such as EMC Report, ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). The manufacturer is WU'S TECH CO., LTD. located in Hsin Chu City, China (Taiwan). The testing is implied to be prospective engineering and material testing rather than retrospective clinical data analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study requiring expert consensus for a "ground truth" on clinical data. The "ground truth" here is the adherence to engineering standards and safety specifications, which is verified through standard testing procedures and certifications (e.g., UL).
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
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 evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Mambo 2 is a powered wheelchair, and its approval process does not involve such studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate device (WU'S POWERED WHEELCHAIR, MAMBO 3, K030707).
- Engineering Standards: Compliance with recognized international and national standards for wheelchairs (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3 for electrical and mechanical safety, strength, fatigue, etc.).
- Material Certifications: Certifications for components like batteries and chargers (e.g., UL certification).
- Control System Clearances: The control systems used are FDA-cleared.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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).