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Model 512 Insulin Pump: The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. BD Paradigm Link Glucose Monitor: The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellius in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertin. Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor: When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication, The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission. The BD Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.

The Paradigm Model 512 external insulin pump is an ambulatory, battery operated, rateprogrammable microinfusion pump, designed for continuous delivery of insulin. A reservoir is driven by a drive motor to deliver preset basal profiles and patient programmed bolus amounts of insulin through infusion sets into subcutaneous tissue. This pump incorporates new software improvements over the predicate model and is designed to allow installation of upgraded software with new features through radio frequency telemetry without the need to replace any pump components. The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds while requiring a very small (0.3 µL) sample. When the BD Paradigm Link Glucose Monitor is used together with the Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link Glucose Monitor can be automatically transmitted to the insulin pump for use in the pump's Bolus Wizard feature. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.

This K030531 document is a 510(k) summary for the Medtronic MiniMed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Monitor. The document describes the devices and their intended use, and states that they were found substantially equivalent to predicate devices. However, this document does not include a study or acceptance criteria related to device performance.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on the provided text. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results and acceptance criteria.

Missing Information from the Provided Text:

• Acceptance Criteria: The document does not specify any quantitative or qualitative acceptance criteria for the performance of either the insulin pump or the glucose monitor.
• Device Performance Data: No specific study data, results, or reported device performance metrics (e.g., accuracy, precision, clinical efficacy) are provided.
• Sample Size for Test Set: There is no mention of a test set sample size for a performance study.
• Data Provenance: Without a study, there's no data provenance to report.
• Number of Experts/Qualifications for Ground Truth: Not applicable as no performance study with ground truth establishment is described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and generally not applicable to the type of devices described (insulin pump and glucose monitor).
• Standalone Performance: While the functions of the devices are described, the document does not present data from a standalone performance study with specific metrics.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable as no machine learning algorithm development (with a training set) is described for the purpose of a performance study.
• How Ground Truth for Training Set was Established: Not applicable.

The provided document serves as a regulatory summary for substantial equivalence determination, not a detailed technical report on performance studies.

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