(139 days)
The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and are limited to a seated position. The Action Trackchair does not require a doctor's prescription.
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The provided document describes a 510(k) premarket notification for a powered wheelchair, the "Action Trackchair: Eagle 16, Eagle 20, Eagle 20, Eagle 24". It confirms that the device is substantially equivalent to legally marketed predicate devices for providing mobility to individuals who need a power wheelchair, can operate one, and are limited to a seated position. The document states that it does not require a doctor's prescription.
However, the provided text is a regulatory clearance letter and does not contain any information regarding acceptance criteria, device performance numbers, specific studies conducted, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device's AI component or its clinical efficacy.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. This type of information would typically be found in a separate clinical study report or a detailed summary of safety and effectiveness, which are not present in this regulatory clearance letter.
§ 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).