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The subject device, the GEMSTAR Infusion Pump, is indicated for intravencus, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

GEMSTAR Infusion Pump

The provided text is a 510(k) clearance letter from the FDA for the Abbott GEMSTAR IV Infusion Pump. It declares the device substantially equivalent to pre-amendment devices for specific indications for use.

Crucially, this document is a regulatory clearance and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the review focused on equivalence to existing devices, not on a new study demonstrating performance against a predefined set of acceptance criteria.

Therefore, I cannot provide the requested information based on the given input. The document does not describe a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.

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