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510(k) Data Aggregation
(78 days)
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a seated position on the scooter and have the capacity to operate a simple hand control.
Model P-33, Three Wheel Electric Scooter
The provided text is a 510(k) clearance letter from the FDA for a "P-33, Battery Operated, Three-Wheel Electric Scooter." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance data from a clinical trial or evaluation study.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. The document does not contain any of these technical details about device testing or evaluation.
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