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The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.

Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.

The proposed device provides for the management of insulin therapy and blood qlucose monitoring by patients with diabetes mellitus. It is comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM) with an embedded blood glucose meter. The PDM incorporates a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value and Insulin on Board (IOB).

The provided text does not contain information about an AI/ML-powered device. Instead, it describes a substantial equivalence determination for the OmniPod Insulin Management System, which is an infusion pump with a built-in glucose meter. The document details modifications to this existing medical device and the performance testing conducted to ensure it remains substantially equivalent to a previously cleared predicate device.

Therefore, I cannot populate the requested table and answer the questions related to AI device acceptance criteria, human reader improvement with AI, or AI ground truth establishment.

The document focuses on the safety and performance of an insulin pump and glucose meter, with no mention of artificial intelligence or machine learning components.

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