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The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom 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 G6 Glucose Program Continuous Glucose Monitoring (CGM) System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous glucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled mobile CGM display.

The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the mobile CGM displays the current glucose reading (updated every 5 minutes) and glucose trends. The mobile CGM display does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.

The subject of this submission is a change to the primary display mobile device software. Compared to the predicate device which uses a standalone mobile CGM application, the proposed Glucose Program System uses a new mobile CGM software module (app module) that is embedded within a third party program provider's mobile app (host app).

This change is to help encourage CGM retention for those not at significant risk of severe hypoglycemia by providing Dexcom Glucose Program CGM functions and program provider's functions on a single unified mobile application. The app module is designed as a finished sovereign software that interacts directly with smart device hardware/operating system and maintains the same core CGM functionality as the predicate device, independent of the host app. The proposed Glucose Program System uses the same sensor/applicator and transmitter as the predicate device, with only changes to the mobile CGM software.

The change to the primary display mobile device software described in this submission does not impact the standalone G6 mobile application used in the G6 CGM System (last cleared K200876) and only affects the Glucose Program System which is designed for payor-sponsored, valuebased health programs.

The document describes the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System and its comparison to a predicate device (K200876). The core of the information provided shows that the new device, referred to as the "subject device," is substantially equivalent to the predicate, with the primary change being a modification to the mobile display software.

Here's an analysis of the provided text in relation to the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it asserts "substantial equivalence" to a predicate device, implying that the subject device meets the same performance standards as the predicate. The description highlights that the subject device "has the same core CGM functionality and meets the same system requirements as the predicate G6 Glucose Program System."

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set that was used to prove the device meets acceptance criteria. It mentions that "All testing referenced in the predicate device (K200876) in accordance with special controls for integrated continuous glucose monitors remain applicable." This suggests that new clinical performance testing with human subjects was not conducted for this specific submission because the underlying hardware and core algorithms are the same as the predicate.

Regarding data provenance (country of origin, retrospective/prospective), this information is also not provided as new clinical trials were not detailed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As stated above, new clinical performance data from human subjects is not detailed for this submission, as the claim is based on substantial equivalence to a predicate device for which such testing would have been performed.

4. Adjudication method for the test set

This information is not provided in the document.

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

This type of study is not applicable to this device. The Dexcom G6 Glucose Program CGM System is a continuous glucose monitoring device, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" in the context of an MRMC study.

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

The device itself is a continuous glucose monitoring system with an onboard algorithm that converts sensor measurements into estimated glucose values. The document states, "The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm." This confirms a standalone algorithm that processes raw sensor data. The claim of substantial equivalence implies that the performance of this standalone algorithm has been previously validated as part of the predicate device's clearance.

7. The type of ground truth used

For a glucose monitoring device, the typical "ground truth" for evaluating accuracy would be laboratory reference standard blood glucose measurements (e.g., from a YSI analyzer). While the document doesn't explicitly state the ground truth used for this specific submission, it relies on the predicate device's clearance, which would have established accuracy against such a standard. The section "Glucose Value Estimation Algorithm" mentions an "Optimized Joint Probability Algorithm with improved data availability," which would be evaluated against such ground truth.

8. The sample size for the training set

The document does not provide information regarding the sample size for the training set. This is likely because the core algorithm remains the same as the predicate device, and new training data for algorithm development is not part of this specific submission.

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

The document does not provide this information. It only states that the "Optimized Joint Probability Algorithm" is used, implying that any training and its associated ground truth establishment would have occurred during the development of this algorithm (likely for the predicate device).

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The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 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 sequential sensor 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 proposed Dexcom G6 Glucose Program Continuous Glucose Monitoring System consists of three main components: the sensor/applicator delivery system, transmitter, and 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 either the Android app (part of the predicate system) or iOS app (part of the proposed system). The app displays the current glucose reading (updated every 5 minutes) and glucose trends from the transmitter. The app alert 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 the Follow mobile application.

This document describes a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System. The submission, K193642, seeks to add an iOS mobile application to an existing Android-based system. As such, the performance data provided largely defers to the existing predicate and reference devices.

Here's an analysis of the provided information concerning acceptance criteria and study data:

Overall Assessment:
The document does not contain explicit acceptance criteria tables with numerical targets, nor does it present detailed performance study results from a new test set for K193642. This is because the core technology (sensor, transmitter, underlying algorithm) and the intended use remain unchanged from the predicate device (K192787) and reference device (K182041). The current submission is primarily for the addition of an iOS application that functions identically to the already cleared Android application. Therefore, performance claims and acceptance are based on the previously cleared devices.

The document states: "All testing performed on the predicate device and reference device in accordance with special controls for integrated continuous glucose monitors remain applicable." and "Therefore, performance testing and software verification and validation testing completed for the predicate device (K192787) remain applicable."

Given this, I will extract information related to what would be the basis for acceptance for such a device, and explicitly note where the information is not present in this specific submission document as a new study.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document (K193642) does not present a new table of acceptance criteria with numerical targets and corresponding performance data from a new study specific to the iOS app's glucose measurement accuracy. Instead, it relies on the predicate (K192787) and reference (K182041) devices for performance.

For a CGM system, typical acceptance criteria and performance metrics would include:

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

• Test Set Sample Size: Not explicitly stated for this specific submission (K193642) regarding new clinical performance data. The submission relies on the data from the predicate (K192787) and reference (K182041) devices. These previous submissions would have contained the sample sizes for their clinical studies.
• Data Provenance: Not explicitly stated for this specific submission. Given Dexcom's nature, previous studies would likely be prospective clinical trials conducted with human subjects. The country of origin for previous studies is not specified in this document, but typically for a US FDA submission, significant clinical data would either be from the US or internationally recognized clinical trials. It implies that data is prospective as it's from clinical trials for performance verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document does not describe the establishment of a "ground truth" using human experts for image or signal interpretation, as it's a CGM device, not an AI diagnostic imaging algorithm. For CGM devices, the ground truth is typically established by laboratory reference methods for blood glucose, not expert consensus. These methods are highly accurate and standardized (e.g., YSI instrument measurements).

4. Adjudication Method for the Test Set

Not applicable in the context of a CGM device performing direct physiological measurements against a reference lab method. Adjudication (e.g., 2+1, 3+1) is typically used in studies where human readers are interpreting complex data (like medical images) and their opinions need to be reconciled to form a ground truth.

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

• Was it done? No, an MRMC study was not done. MRMC studies are relevant for evaluating the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology). This is a continuous glucose monitor; its function is to measure glucose, not to assist human interpretation in the way an AI would.
• Effect Size of Human Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• Was it done? Yes, the core performance of the Dexcom G6 system (sensor, transmitter, and onboard algorithm) is evaluated in a standalone manner against laboratory reference methods. The system autonomously measures and processes glucose data.
• Details: While K193642 itself doesn't present new standalone performance data, it explicitly states that the previous standalone performance testing for the predicate (K192787) and reference (K182041) devices remains applicable. The device "samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm." This "onboard algorithm" is the standalone component, and its accuracy is assessed by comparing its output directly to reference glucose values.

7. The Type of Ground Truth Used

The ground truth for CGM devices is established by laboratory reference blood glucose measurements. These are highly accurate measurements from a venipuncture blood sample, typically performed in a clinical setting using a YSI glucose analyzer or similar highly accurate laboratory method. This is a form of "outcomes data" or "pathology" in the sense of a gold standard for a physiological measurement.

8. The Sample Size for the Training Set

• Not explicitly stated in K193642. The G6 system's core algorithm was likely developed and trained using extensive datasets from previous clinical studies and internal data. The training set size for the original G6 algorithm (from predicate/reference devices) would have been substantial, but this specific submission does not provide those details. Since the algorithm itself is not being fundamentally changed, new training is not the focus of this 510(k).

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

• Not explicitly stated in K193642. For the development and training of the original G6 algorithm (from predicate/reference devices), the ground truth for the training set would have also been established using laboratory reference blood glucose measurements, similar to the test set ground truth. These measurements would be collected concurrently with the sensor readings over a long period from a diverse group of individuals to train the algorithm to accurately translate interstitial fluid glucose signals into blood glucose estimates.

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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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The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 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 sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, 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 G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the predicate Dexcom G6 CGM System.

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 requiring the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016), however, the new app is a separate device from the Share and Follow apps.

The provided text is a U.S. FDA 510(k) summary for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed acceptance criteria for performance, the results of a specific study proving the device meets those criteria, or information on sample sizes, ground truth establishment, or expert involvement.

The document states that the device was "verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors" and that "This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device."

Nonetheless, specific quantitative acceptance criteria and detailed study results are not present in the provided text. To answer your request thoroughly, this information would need to be extracted from a separate clinical study report or a more detailed section of the 510(k) submission that is not included here.

Therefore, I cannot populate the table or provide detailed information for points 2 through 9 based solely on the provided text.

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