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The Dexcom G6 Pro Continuous Glucose Monitoring System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.

The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.

The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices or assessing glycemic variability.

The Dexcom G6 Pro Continuous Glucose Monitoring (G6 Pro) System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM. The predicate of the Dexcom G6 Pro CGM System is the Dexcom G6 CGM System. G6 Pro consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor/applicator is identical to the sensor/applicator used in the G6 CGM System (K191450). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current.

The G6 Pro 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 G6 Pro Transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Pro Transmitter can be used as a retrospective CGM data logger and it can also send realtime estimated glucose values to the G6 Mobile Application. The HCP selects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Pro Transmitter Firmware supports a single-use 10-day sensor session per transmitter.

The G6 App displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 24 hours) from the transmitter.

The provided document is a 510(k) summary for the Dexcom G6 Pro Continuous Glucose Monitoring System. It describes the device, its intended use, and its equivalence to a predicate device. However, the document does not contain the specific details of performance testing, acceptance criteria, or study results in the format requested.

The "Summary of Performance Testing" section (5.8) states: "The proposed Dexcom G6 Pro Continuous Glucose Monitoring 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."

This statement confirms that performance testing was conducted, and the device met its specifications, indicating that there are acceptance criteria and study results. However, the details of these criteria and the reported performance are not included in this summary document.

Therefore, I cannot extract the specific information requested in your prompt based solely on the provided text. To answer your questions, I would need access to the full submission or specific performance study reports that detail:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Without this detailed performance data, I can only state that the document confirms such testing was performed and the device met its specifications.

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