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

The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments.

The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (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 app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow mobile application.

The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.

This is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. The manufacturer, Dexcom, Inc., is seeking to market a device that is substantially equivalent to a legally marketed predicate device. The primary change in the new device is the inclusion of an alternative, ultrasonic-welded transmitter.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly present a table of acceptance criteria and reported device performance in the format of a clinical study summary with specific numerical endpoints and their corresponding achieved values. Instead, it states that:

"The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled."

This implies that the acceptance criteria are met through verification and validation activities aligned with the stated standards and internal processes, but the specific performance metrics (e.g., MARD, accuracy at different glucose levels) are not detailed in this summary. The substantial equivalence argument relies on the fact that the hardware change (transmitter) does not impact the core performance.

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

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described focuses on "performance testing and software verification and validation testing" for the new transmitter and "system integration testing" with the existing mobile app. This suggests technical validation rather than a clinical trial with a patient test set for performance comparison.

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 document. Given the nature of a Continuous Glucose Monitoring (CGM) system, the "ground truth" for glucose measurements is typically established using a laboratory reference method (e.g., YSI analyzer for blood glucose), not expert consensus from medical professionals.

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

The document does not mention any adjudication method. This type of adjudication is typically used in clinical studies where expert review is required for endpoints, which is not directly applicable to the performance evaluation of a CGM system's glucose readings in the same way as, for example, image interpretation.

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 to this device. The Dexcom G6 is a Continuous Glucose Monitoring system that provides direct glucose readings and trends; it is not an AI-assisted diagnostic device that requires human interpretation in the same manner as a radiological imaging system. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply here.

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

Yes, the core performance of the Dexcom G6 system, which includes the algorithm's ability to convert sensor signals into glucose readings, is fundamentally a standalone (algorithm only) performance evaluation. The document states: "The proposed Dexcom G6 Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction." and "The transmitter... converts these measurements into glucose readings using an onboard algorithm." The "performance testing" mentioned validates this standalone function.

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

While not explicitly stated in this summary, for Continuous Glucose Monitoring (CGM) systems, the ground truth for performance testing (e.g., accuracy against reference values) is typically established by laboratory reference methods for blood glucose, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. This is a 510(k) submission for a modification (new transmitter) to an already cleared device, not an initial submission for a novel algorithm where training set details would be more prominently discussed. The original Dexcom G6 system would have undergone extensive training and validation.

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

The document does not provide details on how the ground truth for the training set was established. Similar to the test set, it would have involved laboratory reference methods for glucose measurement during the development of the original Dexcom G6 algorithm.

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