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The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings.

The CADD-Prizm™ Model 6100 ambulatory infusion pump is similar in design, function, and intended use to Abbott Laboratories AIM™ System and Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System). The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one to four delivery applications at one time. The delivery applications supplied for use with the Model 6100 pump and the subject of this 510(k) Notification are the TPN delivery application, continuous delivery application and the intermittent delivery application.

This request cannot be fulfilled. The provided text describes an ambulatory infusion pump, not an AI device or a device that has acceptance criteria based on studies involving test sets, expert ground truth, or statistical analysis of performance metrics typically associated with AI/ML device evaluations. All questions refer to aspects of AI/ML device studies, which are not applicable to this document.

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