(29 days)
The AMP by Method Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
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I'm sorry, but based on the provided text, I cannot answer questions about the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a powered wheelchair device (AMP by Method Mobility), not a detailed study report or clinical trial documentation.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It mentions the indications for use but does not contain information on:
- Specific acceptance criteria metrics (e.g., accuracy, sensitivity, specificity, performance targets).
- Details of a study conducted to prove the device meets performance criteria (such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
To answer your questions, I would need a different type of document, such as a clinical study report, a special controls guidance document, or a more detailed summary of safety and effectiveness for a medical device.
§ 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).