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The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.

The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a standard syringe source container to a patient's vascular system using the Colleague® volumetric infusion pump. The only design difference between the proposed set and other Baxter IV administration sets is the container attachment mechanism which will allow the set to be directly connected to a syringe. This mechanism is an injection molded component which provides a female luer-lock attachment (syringe adapter) and a means for air inlet into the syringe (i.e., vent cap). Therefore, as air enters the syringe, fluid delivery is allowed through the Colleague® Pump Syringe Adapter Set.

The provided text is a 510(k) summary for the Colleague® Pump Syringe Adapter Set, a medical device submission to the FDA. It does not contain information related to acceptance criteria, specific study designs (like MRMC or standalone studies for AI devices), expert qualifications, ground truth establishment, or sample sizes in the context of device performance as one would expect for an AI/CADe device.

The document states: "Data regarding the functional performance of the proposed Colleague® Pump Syringe Adapter Set have been generated and submitted. The data indicate that the proposed set meets or exceeds all functional requirements." However, it does not detail these requirements, the performance metrics, or the specific study design used to verify them.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The submission is for a physical medical device (syringe adapter set), not an AI/CADe system, which is why the requested information about AI device validation is absent.

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