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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 sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes of hyperglycemia, 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 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 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 Dexcom G6 Continuous Glucose Monitoring (CGM) System consists of three main components: a sensor/applicator, 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 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. It 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 receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 CGM System is factory calibrated and does not require user calibration, users of the Dexcom G6 CGM System have the option to calibrate the device (e.g., in situations where users do not have to use the sensor code). When operating in factory calibration mode (using sensor code, the primary mode of G6 CGM System), the G6 algorithm does not require SMBG calibration and instead uses sensor glucose sensitivity estimates determined during manufacturing for EGV calculation. When operating in manual calibration mode (no sensor code), the G6 algorithm relies on daily SMBG calibrations and timematched sensor counts (matched pairs) to estimate calibration parameters for EGV calculation. When a SMBG calibration is entered into the system (in either mode), this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).

The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K191450), but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, there have been no changes to other components of the G6 CGM System (sensor/applicator, transmitter hardware, receiver, and mobile app) introduced by the modified algorithm.

The Dexcom G6 Glucose Program CGM 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 the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends. 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. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 Glucose Program CGM System is factory calibrated and does not require user calibration, users have the option to calibrate the device when operating in factory calibration mode (using sensor code, the only mode of System). When a SMBG calibration is entered into the system, this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).

The proposed G6 Glucose Program CGM System is based on the same physical principles and fundamental design as the commercially available G6 Glucose Program CGM System, but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, the sensor/applicator, transmitter hardware, and mobile app remain unchanged.

This document is a 510(k) premarket notification for the Dexcom G6 Continuous Glucose Monitoring System and the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. The notification aims to demonstrate the substantial equivalence of the modified device to its legally marketed predicate (K191450).

Key Takeaways:

• Device: Dexcom G6 Continuous Glucose Monitoring System and Dexcom G6 Glucose Program Continuous Glucose Monitoring System.
• Modification: Modified algorithm (onboard algorithm) in the transmitter to improve data availability by handling noise events and calibrations better, and to improve detectability of sensors approaching end of life. No changes to other components (sensor/applicator, transmitter hardware, receiver, mobile app).
• Purpose: To demonstrate substantial equivalence to the predicate (K191450) despite the algorithm modification.

While the document highlights the device's intended use and compares it to a predicate device, it does not explicitly provide a table of acceptance criteria and reported device performance with specific metrics (e.g., MARD, accuracy at different glucose ranges). It states that performance testing was done but does not detail the results. Similarly, it doesn't provide information on sample sizes, ground truth establishment methods, or multi-reader studies in the format requested.

Therefore, many of the requested details cannot be extracted directly from this document. The document primarily focuses on demonstrating substantial equivalence based on the intended use and the technological characteristics remaining largely the same, with the algorithm modification being verified and validated internally.

Based on the provided text, here's what can be answered, and what cannot:

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

• Cannot be fully provided. The document states: "This testing demonstrated that the proposed systems performed according to their respective specifications, and the proposed systems have met their respective technological and performance criteria, which have not changed from the predicate device (K191450)."
• It also states regarding the algorithm modification: "The accuracy of the proposed G6 CGM System was demonstrated to meet the iCGM (21 CFR 862.1355) Special Controls requirements (Section 20, Performance Testing - Clinical)."
• However, the specific numerical acceptance criteria (e.g., a certain MARD %) and the actual reported device performance (e.g., the measured MARD) are not detailed in this summary.

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

• Cannot be provided. The document mentions "Performance Testing - Clinical" but does not detail the sample size, data provenance, or whether the study was retrospective or prospective.

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):

• Not applicable / Cannot be provided. This device is a Continuous Glucose Monitor (CGM). Its "ground truth" would typically refer to validated reference glucose measurements (e.g., YSI glucose analyzer, lab-derived plasma glucose). It does not involve human expert interpretation of images that would require multiple readers or their qualifications in the context of imaging.

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

• Not applicable / Cannot be provided. As above, adjudication methods for expert interpretation are not relevant for a CGM's ground truth, which is based on objective glucose measurements.

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:

• Not applicable. This is a standalone device that measures glucose, not an AI-assisted diagnostic tool that human readers would use to interpret medical images.

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

• Yes, implicitly. The core of the device is the algorithm that converts sensor data into estimated glucose values. The document mentions "The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable." The "accuracy of the proposed G6 CGM System" was demonstrated to meet requirements. This refers to the algorithm's performance in generating glucose estimations. The device is intended to "replace fingerstick blood glucose testing for diabetes treatment decisions," implying a standalone measurement accuracy.

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

• Implicitly, reference glucose measurements. For a CGM, the ground truth is established by highly accurate laboratory-grade glucose measurements, typically from venous blood samples analyzed by a calibrated reference method (e.g., YSI glucose analyzer). While not explicitly stated, this is the standard for CGM validation.

8. The sample size for the training set:

• Cannot be provided. The document does not discuss the training set for the algorithm, only the performance testing of the final modified algorithm.

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

• Cannot be provided. As with point 8, the document does not detail the training process or the establishment of ground truth for the training data.

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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 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 several 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 Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control. Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 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 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 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the 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 it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016).

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the Dexcom G6 CGM System. The Dexcom Pro Q System consists of two main components: a sensor/applicator delivery system and a transmitter. 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 logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System are based on the same physical principles and fundamental design as the predicate for each respective System but includes an alternative adhesive patch. The adhesive patch adheres the transmitter wearable to the user's body. The Dexcom G6 System, Dexcom G6 Glucose Program System, and the Dexcom Pro Q System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically.

The provided document is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (a repeated entry, likely an error in the original document format), and Dexcom Pro Q Continuous Glucose Monitoring System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206), Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041), and Dexcom Pro Q Continuous Glucose Monitoring System (K182405).

The document states that the only modification in the proposed devices compared to their respective predicates is an alternative adhesive patch (MA-91 patch vs. Dermamed patch). It explicitly mentions that the proposed systems are based on the "same physical principles and fundamental design" and that their "technological and performance criteria have not changed from the predicate devices."

Therefore, the acceptance criteria and study information would predominantly refer to the performance of the predicate device (or the device with the original adhesive), focusing on the impact of the new adhesive. However, this document does not contain detailed primary performance data, acceptance criteria, or study specifics (like sample sizes, ground truth establishment, or expert qualifications) for the glucose monitoring functionality itself. It only states that the systems were "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 proposed systems performed according to their respective specifications."

Given the limited information in this document, I can only address some of your questions based on what is provided:

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

This document does not provide a table of acceptance criteria for glucose accuracy (e.g., MARD values, Clarke Error Grid analysis) or device performance metrics for the glucose monitoring function. It only states that the devices met their "respective specifications" and that "technological and performance criteria ... have not changed from the predicate devices."

The primary change being submitted for K191450 is a new adhesive patch. Therefore, the "acceptance criteria" for this specific submission would likely revolve around the safety and efficacy of the new adhesive patch (e.g., biocompatibility, adhesion strength, skin irritation). However, these specific criteria and their performance results are not detailed in this document.

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 explicitly state the sample size for any clinical or performance test set, nor does it specify the data provenance (country, retrospective/prospective). It generally refers to "performance testing" and "verification and validation" without providing these details.

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. For glucose monitoring devices, ground truth is typically established using laboratory reference methods (e.g., YSI analyzer for blood glucose), not expert consensus.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used in imaging studies where human readers interpret medical images. Glucose monitoring accuracy studies compare device readings to a reference method.

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

MRMC studies and human reader improvement are not applicable to this type of device (continuous glucose monitor). The Dexcom G6 systems are medical devices that measure physiological parameters, not AI interpretation aids for human readers.

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

The Dexcom G6 systems are standalone in the sense that they continuously measure and report glucose values via an onboard algorithm. The document mentions the transmitter "samples the electrical current ... and converts these measurements into glucose readings using an onboard algorithm." This implies a standalone algorithmic performance for glucose measurement. However, specific details of this standalone performance (e.g., MARD values, accuracy metrics) are not provided in this document, as it mainly focuses on the change in adhesive and substantial equivalence to existing predicates.

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

For continuous glucose monitors, the ground truth for accuracy studies is typically established using a laboratory reference method for blood glucose, such as a YSI glucose analyzer, which provides highly accurate blood glucose measurements. This document does not explicitly state the ground truth method, but this is the standard for CGM validation.

8. The sample size for the training set

The document does not mention any training sets or their sample sizes for the glucose monitoring algorithm. This submission is for devices substantially equivalent to already cleared predicates, and the core algorithm's development and initial training information would have been part of previous submissions (K183206, K182041, K182405).

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

As above, this information is not provided in the document. If an algorithm training set were used for the underlying glucose measurement technology, the ground truth would typically be established using a laboratory reference method for blood glucose.

Summary of what the document does provide regarding acceptance/testing:

• Change: The primary change for this 510(k) is the use of an "alternative adhesive patch" (MA-91 patch) instead of the previous "Dermamed patch."
• Performance Claim: The document asserts that the proposed systems (with the new adhesive) "performed according to their respective specifications" and that "technological and performance criteria which have not changed from the predicate devices."
• Validation: It states that validation was done "according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors."
• Scope: The focus of this particular 510(k) is heavily on demonstrating that the new adhesive patch does not negatively impact the safety and effectiveness of the device, implying that the underlying glucose monitoring performance is unchanged from the predicates.

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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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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 System in an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes providing glucose levels, trends, and alerts. The System consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter and a BLE enabled display device (receiver and/or mobile application). The user can view glucose data on the receiver or on the G6 CGM App (i.e., a mobile medical application) running on a compatible mobile device, or on both simultaneously.

The system provides alerts and alarms which warn the user of low or impending low and high or impending high glucose levels. The user may determine their treatment based on the glucose values provided by the system.

The acceptance criteria for the Dexcom G6 Continuous Glucose Monitoring System and the study that proves the device meets the acceptance criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from 21 CFR 862.1355 (paragraph (v)), which outlines specific performance requirements for iCGM devices in the adult population. The reported device performance is extracted from the provided clinical study data.

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

• Sample Size for Clinical Studies (Test Set):

  • Study 1 & 2 Combined: Total 380 participants (adult and pediatric), with 324 completing the studies.
    • Adults: 159
    • Pediatrics: 165 (encompassing ages 2-17)
  • Acetaminophen Interference Study: 70 subjects.

• Data Provenance:

  • Country of Origin: United States (studies conducted at 11 centers across the US).
  • Retrospective or Prospective: Prospective.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. However, the ground truth comparator method is consistently referred to as a "laboratory-based blood glucose measurement method (Yellow Springs Instrument 2300 STAT plus Glucose analyzer)" or "blood glucose meter" for certain pediatric populations. This implies that the ground truth was established by trained laboratory personnel or healthcare professionals operating these reference instruments, rather than a panel of clinical experts adjudicating cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for the test set. The ground truth was established by direct comparison to laboratory or blood glucose meter readings, which are considered objective measurements. Therefore, an expert adjudication method like "2+1" or "3+1" was not applicable or performed in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The evaluation focuses on the accuracy and performance of the device itself against a comparator method, not on how human readers' performance might improve with or without AI assistance. The device is a continuous glucose monitor for direct patient use and integration with other devices, not an interpretive aid for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary evaluation of the Dexcom G6 System's accuracy, trend accuracy, alert performance, and sensor stability reported in Section L.3 "Clinical studies" appears to be a standalone (algorithm only) performance assessment. The iCGM values are directly compared to laboratory or blood glucose meter comparator methods without human intervention in the device's output or interpretation. The system is designed to provide real-time glucose values autonomously. The human factors study (Section M.3) evaluated user interaction with the device, but the core performance metrics are device-centric.

7. The Type of Ground Truth Used

The ground truth used was:

• Laboratory-based blood glucose measurement method: Specifically, the Yellow Springs Instrument 2300 STAT plus Glucose analyzer was used as the primary comparator for most accuracy assessments. This is a highly accurate and precise laboratory reference method.
• Fingerstick blood glucose testing using a blood glucose meter: Used as a comparator method for pediatric subjects aged 2-5 years and in the acetaminophen interference study alongside the laboratory method.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop the Dexcom G6 System's algorithm. The provided information focuses on the clinical validation (test set) rather than the preceding development and training phases.

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. As common with medical device development, it is assumed that similar laboratory-based reference methods and potentially additional rigorous clinical data would have been used during the development and training phases to establish the ground truth for algorithm optimization, prior to the formal clinical validation studies presented.

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