(135 days)
The Genadyne A4 Powered Suction Pump is intended for general suction use in hospitals or clinics.
The Genadyne A4 powered suction pump is a portable suction device that is intended for general suction use in hospitals or clinics. The Genadyne A4 comes with a canister and a power adapter to charge the battery.
The provided 510(k) summary for the Genadyne A4 Powered Suction Pump does not describe a study involving acceptance criteria or the performance of an AI device. This document is for a medical device that generates suction and is a standard 510(k) premarket notification for a Class II device.
The information provided describes a comparison to a predicate device to establish substantial equivalence for regulatory approval, focusing on physical and performance characteristics of the suction pump itself, not on an AI system's diagnostic or predictive capabilities.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device. The document simply lists technical specifications and intended use of a physical suction pump.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.