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For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

The iXL Diabetes Management System has two (2) components: a Remote Controller, and an insulin infusion Pump, and two accessories; a fill syringe, and fill needle.

The Remote Controller is a hand held, battery-operated device, with 9 functional buttons and an electro-luminescent (EL) backlit liquid crystal display (LCD). The device provides audio alarms, alerts and reminders.

The Pump is activated and controlled exclusively through the use of the Remote Controller. The Pump and Remote Controller interact wirelessly using secure, radio frequency (RF).

The Pump is a microprocessor controlled device. The Pump is worn directly on the body in the same manner and general locations as a conventional insulin infusion set. The Pump will leliver insulin based on the users custom programmed basal rate and bolus does for up to 72 houvs. The Pump provides audio alarms, alerts and reminders.

This document does not contain the information required to populate the requested table and answer the questions. The provided text is a 510(k) summary for the iXL™ Diabetes Management System, focusing on substantial equivalence to a predicate device for marketing purposes.

Specifically, the document lacks details regarding:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics, thresholds, or results are reported to demonstrate the device meets any set acceptance criteria. The document focuses on comparing the new device's design and intended use to a predicate device, not on quantitative performance outcomes.
• Study Details: There is no mention of a study design, sample sizes (for test or training sets), data provenance, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• Ground Truth: The type of ground truth used or how it was established (for either training or testing) is not discussed.

The 510(k) process primarily evaluates a new device's substantial equivalence to an already legally marketed device (predicate device) based on similar technological characteristics and intended use, rather than requiring extensive clinical efficacy or performance studies with acceptance criteria and detailed study designs as might be found in a PMA or a more comprehensive clinical trial report.

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