(134 days)
The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a US FDA 510(k) substantially equivalent letter for a powered wheelchair (Trade/Device name: Tacahe, later identified as ELEXUS(PC-1450)). It primarily addresses the regulatory approval process, confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory requirements. The "Indications for Use" section simply describes the intended purpose of the wheelchair.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
§ 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).