(42 days)
The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.
AmySystems PTS50CG Weight Shift Power Tilt System
The provided text is a 510(k) clearance letter from the FDA for a medical device called "AmySystems PTS50CG-50° Power Tilt System." This document grants market clearance based on substantial equivalence to a predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in your prompt.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical studies with detailed performance metrics and statistical analyses as might be found in a PMA (Premarket Approval) application.
Therefore, I cannot populate the table or answer the specific questions based on the information provided in the input text. The document confirms the device's clearance for marketing and its intended use but does not delve into the technical study details you are asking for.
§ 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).