(156 days)
The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
The subject device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.
The drive system e-fix E35/E36 includes two power wheels, a battery mount, a battery pack, a control unit, a power supply and optional devices. The wheelchair is not part of the drive system and is provided by the customer. For initial use mounting brackets are required. If the mounting brackets are fitted to the wheelchair, the power wheels, the control unit and the battery pack can be adapted. The main principle of the power wheel is that the motor unit is fixed against turning and the wheel hub is rotating. The fixing of the motor unit to the mounting brackets is realized with the wheel receiver. The wheel receiver supports the torque which the motor applies and is the interface to the wheel chair.
There are different variants of the e-fix E35 is the conventional version of the e-fix. The e-fix E36 provides a more robust drive with a higher torque. The battery pack has more capacity than the normal one. The e-fix E36 is mainly intended for heavy-weighted persons. The e-fix E35 and E36 are available with 22" or 24" wheels. The control unit is the steering device of the system. It allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.
The provided document is a 510(k) summary for a medical device called e-fix E35/E36, which is an add-on drive for wheelchairs. It outlines the device's technical specifications, indications for use, comparison to a predicate device, and conformity with standards.
However, the document does not contain the specific information requested regarding the acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. This device is a powered wheelchair accessory, and the FDA submission focuses on its mechanical, electrical, and performance characteristics as a physical medical device, not an AI/ML-driven diagnostic or analytical tool.
Therefore, I cannot extract the requested information from the provided text. The document describes conformity to ISO standards for wheelchair performance and safety, but these are not the "acceptance criteria" in the sense of accuracy, sensitivity, specificity, etc., typically associated with AI/ML device evaluations. There is no mention of a "study" in the context of evaluating an AI algorithm's performance against a ground truth.
If you have a document pertaining to an AI/ML medical device, please provide that.
§ 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).