(8 days)
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
The Power Wheelchair consists of two basic sections to complete the finished component.
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The powerbase containing motors, batteries, charger and wheels.
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The body support system containing contoured adjustable seating and the joystick dual integrated controller.
The UB 114 consists of two motor gearbox combinations that power two 14" diameter front drive wheels. The electrical power source comes from two gel-cell type batteries placed in electrical series for a 24-volt direct current application. Motor control and the battery recharging monitoring is from a Joystick Controller. As part of the electrical system the UB114 employs a battery charger which is mounted "onboard" the power base.
Rear weight, rear balance and rear force load distribution is achieved by two vertical articulating caster wheels. These wheels are mounted directly to the power base. The caster wheels rotate a full 360-degree movement about the vertical mount axis while supporting the rear force load.
Constructed fully from Aluminum Alloy this Power Chair is the first in its class to have a Uni-Body style frame. All key electrical components, batteries, motor gearboxes, battery charger and wiring are enclosed within the Uni-body frame. The exterior is finished in a high performance and durable epoxy type paint.
The UB114 also employs a set of front stabilizer wheels that are placed to the front centerline of the drive wheels. The stabilizer wheels aid the user if they encounter a situation that may create an unsafe situation and help keep the Powered Wheelchair from tipping forwards or to the front left or front right sides.
The front stabilizer wheels and support arms also aid in the protection for the user's feet and legs.
All electrical components (motor gearbox combinations, batteries, battery charger, and internal wring) are housed/enclosed within a solid aluminum alloy Unibody frame.
The body support system contains contoured adjustable seating with a full 180degree tilt back for the user. A puff-bladder style or cam-lock style lumbar support is standard for all seating in the UB114.
The joystick controller attached to the seating system with a combination length adjustment and tilt angle plate system. This allows the user to totally custom fit the angle and length of position for the joystick.
The provided text is a 510(k) summary for a powered wheelchair (UB 114) and does not describe an AI/ML medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for an AI/ML device.
The document focuses on demonstrating substantial equivalence of the UB 114 powered wheelchair to a predicate device based on non-clinical tests.
Here's a breakdown of the information that is present, relating to the non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to a list of tests from a Guidance Document for Premarket Notification for wheelchairs. It states that the device was tested against these standards.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/02 1991 Static Stability | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
| ANSI/RESNA WC/02 1991 Dynamic Stability | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
| ANSI/RESNA WC/Vol. 2-1998 EMC Testing | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable for a non-AI physical device. The testing would have been performed on the physical wheelchair prototype.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable for a non-AI physical device. The "ground truth" for a physical device is its performance against engineering and safety standards.
4. Adjudication Method:
Not applicable for a non-AI physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable as this is not an AI device aimed at assisting human readers/interpreters.
6. Standalone Performance:
The "standalone" performance for this physical device is its ability to directly meet the ANSI/RESNA standards. The conclusion states: "The non-clinical testing and predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This implies the device performed adequately in these tests on its own.
7. Type of Ground Truth Used:
For this type of physical device, the "ground truth" is adherence to established engineering and safety standards (ANSI/RESNA WC/02 1991 for Static Stability, Dynamic Stability, and WC/Vol. 2-1998 for EMC Testing).
8. Sample Size for the Training Set:
Not applicable for a non-AI physical device. There is no concept of a "training set" for physical product testing in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for a non-AI physical device.
Summary of missing information specifically for an AI/ML device (as requested in the prompt, but not present in the document):
- Details on dataset sizes (test, training).
- Data provenance for clinical data (country, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods for clinical ground truth.
- MRMC study details and effect size.
- Standalone algorithm performance metrics (e.g., sensitivity, specificity, AUC).
- Specific types of ground truth for clinical endpoints (e.g., pathology reports, long-term outcomes).
- Methods for establishing ground truth for training data.
§ 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).