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The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G6 Continuous Glucose Monitoring System consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The Dexcom G6 System does not require calibrations using SMBG, and the sensor life has an expected wear time of up to 10 days. The receiver and/or mobile app displays the current glucose reading and glucose trends to the user. It alerts the user when glucose levels are outside of a target zone and when other important system conditions occur.

The Dexcom G6 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter. The proposed Dexcom G6 System is based on the same physical principles and fundamental design as the commercially-available Dexcom G6 System (DEN170088), but has modifications to physical design, software, and hardware of the transmitter. The Dexcom G6 System is designed to function as intended with either the proposed, or current G6 transmitter. The proposed G6 transmitter has the same form, fit, and function as the commercial G6 transmitter and, from the users' perspective, functions identically.

This document is an FDA 510(k) premarket notification for the Dexcom G6 Continuous Glucose Monitoring System, focusing on a modification to the transmitter. It does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study. Therefore, some of the requested information, particularly quantitative results and specific methodologies for establishing ground truth, cannot be extracted from this document.

However, based on the provided text, here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

The document states that the proposed Dexcom G6 System meets all required performance criteria for the predicate Dexcom G6 System. However, the specific acceptance criteria and the quantitative performance metrics (e.g., MARD, accuracy at different glucose ranges) are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. The document only states that the device was "verified and validated" through performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. For continuous glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) measuring blood glucose, not by expert review in the same way it would be for imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the summary. Adjudication is not typically applicable in the same way for CGM performance testing where objective measurements are compared against a reference.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable here. This device is a continuous glucose monitoring system, not an AI-assisted diagnostic imaging tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the performance testing for a CGM system fundamentally assesses the standalone algorithm and hardware performance in measuring and reporting glucose levels. The document states: "The proposed Dexcom G6 System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device." While human users interact with the device, the core performance evaluation concerns the accuracy of the glucose readings generated by the system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For continuous glucose monitoring systems, the ground truth is typically established by laboratory reference methods to measure blood glucose concentrations. The document does not explicitly state the method, but this is the standard for CGM validation.

8. The sample size for the training set

This information is not provided in the summary. The document describes modifications to an existing device (Dexcom G6, DEN170088) that already had its algorithm developed and validated. The current submission focuses on a new transmitter design, implying that the core algorithm trained on previous data remains largely unchanged ("The Dexcom G6 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter").

9. How the ground truth for the training set was established

This information is not provided in the summary, as the training set details for the original Dexcom G6 algorithm are not within the scope of this particular submission for a transmitter modification. However, as with point 7, it would typically involve laboratory reference methods for blood glucose determination.

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