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The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The proposed device, the Alpha Infusion Pump, is an elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external, disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) summary and approval letter for an infusion pump, focusing on its substantial equivalence to predicate devices and regulatory compliance rather than performance study results.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and study that proves it meets them.

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