(51 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is Magnesium alloy. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
The provided text is a 510(k) summary for an Electrically Powered Wheelchair (device name: HP558) and does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic applications.
The document discusses the substantial equivalence of the proposed device to a predicate device (HP458E) by comparing their design, functionality, materials, and compliance with various ISO and IEC standards relevant to wheelchairs. It also mentions performance data to verify that the subject device meets design specifications, but this is in the context of standard engineering and safety testing for a medical device (electrically powered wheelchair), not a study assessing AI/ML model performance.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance: This document lists various technical specifications and safety standards for the wheelchair itself, not performance metrics of an AI algorithm.
- Sample size, data provenance, number of experts, adjudication method for the test set: These are relevant to studies evaluating AI/ML models on a dataset, which is not what this document describes.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance (algorithm only): The device is a physical wheelchair, not an algorithm.
- Type of ground truth used: This concept is not applicable to the evaluation described.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory submission for a physical medical device (an electrically powered wheelchair) and focuses on ensuring its physical safety, effectiveness, and substantial equivalence to an existing device through engineering and biocompatibility testing against established standards. It does not involve AI or diagnostic imaging.
§ 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).