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The Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood.

The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

The Symphony System combines the use of an insulin pump and a blood glucose meter for the treatment of insulin requiring diabetes. The insulin pump, Symphony Pump, operates as a stand alone device to deliver insulin through an infusion set placed subcutaneously. The blood glucose meter, Symphony Meter Remote, operates as a stand alone device to measure blood glucose concentrations. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.

The provided 510(k) summary for the Symphony Glucose Management System states that "Performance evaluations, both bench and clinical, of the Symphony System were completed and did not raise any new issues of safety and efficacy." However, it does not include specific acceptance criteria or detailed results of these performance evaluations. Therefore, I cannot extract the information requested for a table of acceptance criteria and reported device performance directly from this document.

Similarly, since the detailed study results are not present, I cannot provide details on sample sizes, ground truth establishment for test and training sets, expert qualifications, adjudication methods, or MRMC study results.

This document focuses on establishing substantial equivalence to predicate devices based on device description, intended use, and a general statement about concluded performance evaluations, rather than providing the detailed technical and clinical study report.

In summary, the requested information regarding acceptance criteria and detailed study results is not present in the provided 510(k) summary.

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