(291 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Wu's Powered Wheelchair, Mambo 30, is an indoor-use electric wheelchair that is battery operated. It has a base with six-wheeled with a seat and armrest. The movement of the wheelchair is controlled by the rider who uses joystick, located at the right-side armrest, to control the direction and speed of the wheelchair. The device is provided with an off-board battery charger. The maximum weight capacity of Mambo 30 is 300 lbs. (136 kg), and its maximum speed is 4 mph (6.4 km/h).
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Wu's Powered Wheelchair, Mambo 30. The document focuses on demonstrating substantial equivalence to a predicate device, the Wu's Powered Wheelchair, Mambo 36, primarily through performance testing against recognized standards.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly uses international and domestic standards as acceptance criteria for various aspects of the powered wheelchair. The reported device performance is indicated by its compliance with these standards.
| Acceptance Critieria (Standard) | Reported Device Performance (Compliance/Result) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Passed |
| ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Passed |
| ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes | Passed |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range | Passed |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space | Passed |
| ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Passed |
| ISO 7176-7:1998 Wheelchairs - Part 7: Determination of seating dimensions -Definitions and measuring method | Passed |
| ISO 7176-8:2014 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs | Passed |
| ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs | Passed |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Passed |
| ISO 7176-11:2014 Wheelchairs -- Part 11 Test dummies | Standard utilized in testing |
| ISO 7176-13: 1989 Wheelchair - Part 13: Determination of coefficient of friction of test surfaces | Passed |
| ISO 7176-15: 1996 Wheelchairs -- Part 15: Requirements for information disclosure, documentation and labelling | Passed |
| ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices | Passed |
| ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Passed |
| ISO 7176-25:2013 Wheelchairs -- Part 25: Batteries and chargers for powered wheelchairs | Batteries passed testing; Charger passed testing |
| ANSI/RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs-- Requirements and test methods. | Electronic controller passed testing |
| ANSI/RESNA WC-2:2009 Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. | Passed |
| ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Biocompatibility Assessment performed for patient-contacting parts (Headrest/Seatback/Seat/Safety seat belt, Armrest, Horn button, Speed dial, REM060/110 bottom case, REM050/100 (Full joystick control module)). Specific tests (Cytotoxicity, Maximization Sensitization, Skin Irritation, Irritation & delayed-type hypersensitivity (Epicutan test)) conducted as listed. |
2. Sample size used for the test set and the data provenance:
The document describes performance testing based on ISO and ANSI/RESNA standards for powered wheelchairs. These standards typically involve testing a single device or a small representative sample of the manufactured device to ensure it meets the specified engineering and safety requirements. The document does not specify a numerical sample size beyond implying testing of "the device" (singular) or its components.
The data provenance is from non-clinical tests conducted by the manufacturer, Wu's Tech Co., Ltd., based in Taiwan, R.O.C. The data is prospective in the sense that the device was actively tested against the standards to demonstrate compliance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of submission (510(k) for a powered wheelchair) does not typically involve human expert consensus for "ground truth" in the way a diagnostic AI device would. The "ground truth" here is objective compliance with established engineering and safety standards. The experts involved would be the engineers and technicians conducting the tests in accordance with the specified ISO and ANSI/RESNA standards, as well as the regulatory reviewers at the FDA who assess the submitted test reports. Their qualifications are implicitly that they are competent in performing and interpreting these engineering tests. The document does not specify the number or specific qualifications of these individuals but relies on the adherence to recognized standards.
4. Adjudication method for the test set:
Not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for diagnostic accuracy, which is not the nature of these engineering performance tests. The "adjudication" is essentially the successful completion and documentation of tests aligned with the specified standards.
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:
No. This is a powered wheelchair, not a diagnostic imaging device utilizing AI. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device. "Standalone performance" in the context of an algorithm is not applicable here. The device's performance is inherently tied to its physical interaction with users and the environment, albeit controlled by electronic systems.
7. The type of ground truth used:
The ground truth used is compliance with established international and national performance and safety standards (ISO 7176 series and ANSI/RESNA WC-2 series), and biocompatibility testing standards (ISO 10993-1). This is an objective, measurable ground truth for engineering and material safety.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and performance are based on engineering principles and compliance with fixed standards, not on learning from a dataset.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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).