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The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypodlycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the interstitial fluid, calculate the qucose reading and make this available to the user. The G7 System is intended for single patient use at home and requires a prescription.

The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver).

To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.

The G7 is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from compatible electronic interfaces via the following secure wireless connections:

• Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol

· The Mobile App communicates to another app on a single mobile platform

· The Mobile App communicates through the cloud to another software device

o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Principle of Operation:

The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

The provided text is a 510(k) summary for the Dexcom G7 Continuous Glucose Monitoring System. It states that the device is substantially equivalent to a previously cleared Dexcom G7 Continuous Glucose Monitoring System (K234133). The key difference between the subject device and the predicate device is limited to "BLE communication and associated labeling updates." Crucially, it explicitly states: "No design change was required to support the extended BLE communication." and "No clinical data was necessary to determine substantial equivalence."

Therefore, the only acceptance criteria and study that proves the device meets the acceptance criteria mentioned in this document pertain to this specific change:

Acceptance Criteria and Study for Dexcom G7 Continuous Glucose Monitoring System (K240902)

Given that the submission is for an updated version of an already cleared device (Dexcom G7 K234133) and the only difference noted is related to BLE communication and associated labeling updates, with no design change, the acceptance criteria and study detailed here are specific to proving the extended BLE communication functionality.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "No design change was required to support the extended BLE communication." and "No clinical data was necessary to determine substantial equivalence." This implies that the testing for the BLE communication range was likely a non-clinical bench top or engineering test.

• Sample Size: Not specified in the provided text, but it would pertain to the number of devices or test repetitions used in the communication range testing.
• Data Provenance: Not specified, but generally, non-clinical engineering tests would be controlled laboratory environments. It is implicitly prospective testing conducted specifically for this regulatory submission.

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

• This information is not applicable for the specific testing described. The acceptance criteria for BLE communication range would be met through quantitative measurements (e.g., signal strength, data transmission success rate over distance) against a pre-defined engineering specification, not through human expert assessment or ground truth establishment in the traditional sense for medical device diagnostics.

4. Adjudication Method for the Test Set:

• This information is not applicable for the specific testing described. Adjudication methods are typically used in clinical studies or image review settings involving human interpretation. The BLE communication range testing would rely on automated data collection and comparison to a specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not applicable. This submission is for a continuous glucose monitoring system, not an AI-assisted diagnostic imaging device. The document explicitly states, "No clinical data was necessary to determine substantial equivalence."

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

• The primary "performance" discussed for this specific 510(k) is the extended BLE communication range. This would be assessed as a "standalone" technical capability of the device's communication module, without direct human intervention in the communication process itself. However, it's not an "algorithm only" performance assessment in the sense of AI diagnostics.

7. The Type of Ground Truth Used:

• For the BLE communication range, the "ground truth" would be the engineering specification for the extended communication range itself, against which the measured performance of the device's BLE module is compared. It's a quantitative, pre-defined target.

8. The Sample Size for the Training Set:

• This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning model where a distinct training phase is described.

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

• This information is not applicable for the same reason as above.

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The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous qlucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypodlycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user.The G7 System is intended for single patient use at home and requires a prescription.

The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver).

The proposed G7 CGM System is modified to allow users to display glucose data directly from the transmitter on compatible iOS smartwatches.

To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.

The G7 is an interoperable connected device that can communicate glucose readings and other information wirelessy and securely to and from compatible electronic interfaces via the following secure wireless connections:

• · Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
• · The Mobile App communicates to another app on a single mobile platform
• · The Mobile App communicates through the cloud to another software device o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Principle of Operation:

The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria, especially regarding a table of acceptance criteria and reported device performance, sample size for test and training sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) premarket notification letter from the FDA to Dexcom Inc. for their G7 Continuous Glucose Monitoring System, confirming its substantial equivalence to a predicate device. It briefly mentions non-clinical testing performed to establish performance characteristics related to the "Direct to Watch (DTW) feature" (EMC, communication range, human factors, software V&V, cybersecurity) and states that these tests demonstrate the system meets "pre-defined acceptance criteria." However, it does not detail what those acceptance criteria are or present the performance results against them. It also explicitly states, "No clinical data was necessary to determine substantial equivalence."

Therefore, I cannot fulfill your request for the detailed information as the source text does not provide it.

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The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable connected device that measures and displays estimated glucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. 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 sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.

The molded transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is a single button press vertical spring deployed mechanism which introduces the sensor via the needle into the subcutaneous tissue, while also placing the embedded wearable onto the body which adheres to the skin via an adhesive patch.

After deployment, the molded transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts glucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices which present the current qlucose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously.

The G7 System is also designed to communicate estimated glucose values, trend and system information to other compatible electronic interfaces via the following secure wireless connections:

• Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
• . The app communicates to another app on a single mobile platform
• . The app communicates through the cloud to another software device.
• Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable o secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

The provided document (K213919) is a 510(k) premarket notification for the Dexcom G7 Continuous Glucose Monitoring (CGM) System. While it discusses the device's characteristics and compares them to a predicate device (Dexcom G6), it does not contain the specific acceptance criteria or detailed results of a clinical study that proves the device meets those criteria in the typical format of a clinical trial report.

The document states:
"The Dexcom G7 CGM System was verified and validated according to Dexcom's internal design control processes and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the System performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device."

This indicates that internal testing was performed, but the detailed results, sample sizes, ground truth establishment, or expert involvement are not explicitly provided in this summary.

Therefore, I cannot fully provide all the requested information. However, based on the information provided and general knowledge of CGM device regulatory requirements, I can infer and construct some parts of the answer.

Here's an attempt to answer your request based on the available information and reasonable assumptions for a 510(k) submission for a CGM device:

Device: Dexcom G7 Continuous Glucose Monitoring System (K213919)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data. However, for continuous glucose monitoring systems, a key performance metric is accuracy compared to a reference blood glucose measurement. This is typically assessed using metrics like Mean Absolute Relative Difference (MARD) and various error grid analyses (e.g., Consensus Error Grid, Parkes Error Grid).

Inferred Acceptance Criteria (Typical for iCGM) and Assumed Reported Performance (Based on 510(k) Clearance for a similar device):

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

The document does not specify the exact sample size for the clinical test set. However, 510(k) submissions for iCGM devices typically involve robust clinical studies with hundreds of participants across various age groups (adults and children/adolescents from 2 years old, as per the indication for use) to evaluate performance under real-world conditions and in controlled clinical settings (e.g., hyperglycemic and hypoglycemic clamps).

The data provenance is not specified. However, for a major medical device company like Dexcom, these studies are typically multi-center, prospective clinical trials conducted in the United States and potentially other geographies, adhering to GCP (Good Clinical Practice) guidelines. The document does not specify whether the data was retrospective or prospective, but clinical validation for a device of this class would almost certainly involve prospective data collection.

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

For CGM device validation, ground truth is not established by "experts" in the sense of image readers, but rather through highly accurate laboratory reference methods.

• Ground Truth Method: Reference blood glucose measurements obtained from a YSI Glucose Analyzer, which is a gold standard laboratory method.
• Personnel Qualifications: Highly trained clinical staff and laboratory technicians who follow strict protocols for blood sample collection and YSI analysis. Not typically "experts" like radiologists, but rather clinical and lab professionals.

4. Adjudication Method for the Test Set:

Not applicable in the context of a CGM device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting images or other subjective data, and a consensus or authoritative reading is needed for ground truth or comparison. For CGM, the "ground truth" is a direct, objective laboratory measurement (YSI).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

Not applicable. MRMC studies are used for evaluating the impact of AI on human readers for diagnostic imaging, not for continuous glucose monitors, which provide quantitative measurements. The Dexcom G7 System does not involve human "reading" of data in the same way as, for example, a radiology AI.

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

Yes, in essence. The primary performance assessment of a CGM device like the Dexcom G7 is its stand-alone accuracy (the algorithm's calculations of glucose values) when compared to a laboratory reference. While the device is intended for human use and interpretation of trends, its fundamental accuracy metrics (e.g., MARD, Error Grid analysis) represent the performance of the device's sensor and algorithm without human intervention in the primary glucose measurement and calculation. The "human-in-the-loop" aspect comes into play with treatment decisions, but the device's numerical output itself is an "algorithm only" performance metric.

7. The Type of Ground Truth Used:

The ground truth used for validating the Dexcom G7's accuracy would be concurrent blood glucose measurements obtained from a YSI Glucose Analyzer (or an equivalent traceable clinical chemistry laboratory method). This is considered the gold standard for glucose measurement in clinical studies.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size for the training set. For data-driven medical devices like CGMs, the training data (for calibration algorithms, signal processing, etc.) is typically derived from extensive internal research and development studies, often involving hundreds to thousands of sensor wear periods and millions of data points collected over years. This data would encompass a wide range of glucose values, patient populations, and physiological conditions to ensure the algorithm is robust.

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

The ground truth for the training set would be established in the same manner as the test set: through concurrent, highly accurate laboratory reference blood glucose measurements (YSI) taken alongside CGM readings. This ensures that the algorithm learns from precise and reliable reference data. These training data sets often include induced hypoglycemia and hyperglycemia to ensure algorithm performance across the full dynamic range of glucose.

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