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The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.

The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System consists of an insulin infusion pump (Aviator Pump) and a wireless remote controller (Aviator Companion). The Aviator Pump was previously cleared by the FDA on January 11, 2008 (K071788).

The Aviator Companion is a handheld, microprocessor controlled, battery powered, remote control device for the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System. The Aviator Companion provides an alternate user interface to the Aviator Pump which is useful when the pump is hidden under clothing.

The Aviator Companion user interface can control specific pump functions and receive pump status information. The Companion contains a large graphical LCD, jogwheel and tactile push buttons. Both the Aviator Companion UI and the Aviator Pump UI consistently utilize text, icon and graphical presentations to prompt the user through the menus and to present data.

The Ayiator Companion incorporates the FreeStyle Lite Blood Glucose Monitoring System (BGMS). The Aviator Companion has a built-in test strip port that utilizes the FreeStyle Lite Test strip. The FreeStyle Lite BGMS received FDA clearance on April 10, 2007 (K070850).

This is a 510(k) premarket notification for the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a full study report with precise performance metrics.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or quantified device performance metrics for the blood glucose monitoring component beyond stating that a "blood glucose clinical study" was conducted. It emphasizes that design verification testing, a blood glucose clinical study, and software validation verified the requirements stated in the specification documents. However, the actual performance values that met those requirements are not provided in this summary.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for the blood glucose clinical study.
• Data Provenance: Not explicitly stated, but the submission is from Abbott Diabetes Care in Alameda, CA, USA, suggesting the study likely took place in the US, but this is not confirmed. It does not mention if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method, not by expert consensus from individuals like radiologists.

4. Adjudication Method

This information is not applicable and therefore not provided, as the ground truth for blood glucose measurements is typically a laboratory reference method, not an expert panel requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable to a blood glucose monitoring system. MRMC studies are typically used to assess the effectiveness of diagnostic imaging systems where human readers interpret medical images.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was implicitly done for the blood glucose monitoring component. The document states "a blood glucose clinical study" was conducted, and the Aviator Companion incorporates the FreeStyle Lite Blood Glucose Monitoring System (BGMS) which "received FDA clearance on April 10, 2007 (K070850)." This indicates that the performance of the blood glucose monitoring function itself was evaluated independently. However, specific performance metrics from this study are not detailed in this 510(k) summary. The summary refers to the fact that the BGMS component was previously cleared, suggesting its standalone performance was established in its own prior submission.

7. Type of Ground Truth Used

While not explicitly detailed in this document for this submission, for a blood glucose monitoring system, the ground truth for the "blood glucose clinical study" would almost certainly be laboratory reference measurements (e.g., from a YSI analyzer or similar gold-standard laboratory instrument) on the same blood samples.

8. Sample Size for the Training Set

This information is not provided. Blood glucose meters typically do not use machine learning in the conventional sense that would require a "training set." Performance is evaluated against clinical samples. If any calibration or algorithm development involved data, it's not described as a "training set" here.

9. How the Ground Truth for the Training Set Was Established

As above, this information is not provided and is likely not applicable in the typical sense of a machine learning "training set" for a blood glucose monitor. Ground truth for performance evaluation would be established by laboratory reference methods.

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