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The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir is intended for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The AutoMed 3000 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set AM 330 and accessories are part of the overall system. The system is suitable for use as ambulatory devices and is intended for use in the hospital, home environment or alternative care sites.

This 510(k) summary for the AutoMed 3000 infusion pump does not contain the detailed acceptance criteria or a study proving that the device meets those criteria, nor does it provide information relevant to AI/ML device evaluations.

The document is a traditional 510(k) submission for an infusion pump, which focuses on demonstrating substantial equivalence to legally marketed predicate devices based on device description, intended use, and technological characteristics. The provided text is a summary of the 510(k) notification and the FDA's response letter determining substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI comparative effectiveness studies. These are not typically part of a 510(k) summary for a non-AI medical device like an infusion pump.

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