(15 days)
The X-Change wheelchair family is designed mostly for adults who require assistance in the use of a device to assist them with their mobility needs.
Not Found
I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter for a mechanical wheelchair, the X-Change, and it primarily focuses on the regulatory approval process based on substantial equivalence to a predicate device.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study conducted to prove the device meets specific performance criteria.
- Information about sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.
The document states that the FDA reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the device has the same intended use and the same technological characteristics as the predicate device, or if it has different characteristics, the new characteristics do not raise different questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate device. However, it does not provide the specifics of any performance studies that would typically be associated with acceptance criteria.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).