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The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older.

The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is an interoperable continuous glucose monitoring system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The Dexcom G7 15 Day CGM System is intended for single patient use at home and requires a prescription.

The G7 15 Day consists of the following primary components: a wearable, consisting of a sensor and transmitter worn on the body and a display device, which can be a G7 Mobile Application (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 15 Day, 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 display device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 15 Day 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 15 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 Dexcom G7 15 Day CGM System 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
  • 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 15 Day CGM System remain the same as prior generations of Dexcom CGM Systems. The 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 FDA 510(k) clearance letter and summary for the Dexcom G7 15 Day CGM System outlines several acceptance criteria and the studies performed to meet them. However, it's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements. It does not provide the detailed numerical performance metrics typically found in a full clinical study report, nor does it specify exact numerical "acceptance criteria" in all cases, instead referring to meeting "specifications" or "special controls."

Here's an attempt to extract the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states:

• "A clinical study was conducted to evaluate the safety and effectiveness of the Dexcom G7 15 Day CGM System... in adult (18 years and older) participants with diabetes."
• "A subsequent clinical study was performed to assess the impact of a new sensor patch intended to improve survival rate."
• "A separate clinical study was performed in adults with type 1 and type 2 diabetes to assess the data transmission reliability over the 15-day wear period."

Sample Size: The exact sample size (number of participants) for these clinical studies is not specified in the provided text.

Data Provenance:

• Country of Origin: Not specified in the document.
• Retrospective or Prospective: Clinical studies are generally prospective, especially when evaluating safety and effectiveness of a new device. The phrasing "A clinical study was conducted to evaluate..." implies a prospective study.

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

This information is not provided in the given document. For a CGM device, the ground truth for glucose measurements is typically established using a highly accurate reference method, such as a YSI glucose analyzer, rather than expert interpretation of images or observations.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For a continuous glucose monitoring system, the ground truth is established by objective laboratory measurements (YSI). Therefore, an adjudication method for the test set in the traditional sense is not applicable or described.

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

An MRMC study is relevant for devices where human readers interpret data, often with or without AI assistance.

• Was an MRMC study done? No, an MRMC study was not described. The Dexcom G7 is a diagnostic device that provides quantitative glucose values, not an imaging or interpretive AI, so comparative effectiveness with human readers in the traditional MRMC sense is not relevant here.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study was conducted or described for this type of device.

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

Yes, a standalone performance assessment was done. The clinical study evaluating "safety and effectiveness of the Dexcom G7 15 Day CGM System... with respect to reference venous plasma sample YSI measurements" directly assesses the algorithm's performance without human interpretation of the CGM readings. The device is intended "to generate continuous glucose measurements and make this available to the user," and the study uses these generated measurements against a gold standard.

7. Type of Ground Truth Used

The primary ground truth for the clinical effectiveness study was:

• Reference venous plasma sample YSI measurements.
  This is a highly accurate laboratory method for measuring glucose in blood, considered the gold standard for comparing CGM performance.

8. Sample Size for the Training Set

The document focuses on the new clinical data submitted for the Dexcom G7 15 Day CGM System and refers to its substantial equivalence to the predicate "Dexcom G7 Continuous Glucose Monitoring System." The sample size for the training set (i.e., data used to develop the algorithms for the CGM) is not mentioned in this 510(k) summary. This information would typically be developed during the device's original design and development phase, not necessarily recounted in each subsequent 510(k) submission unless there were significant algorithm changes requiring new training data.

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

Similar to item 8, the process for establishing ground truth for the training set used during the development of the Dexcom G7 algorithms is not described in this document. It is highly probable that similar reference methods (like YSI venous plasma measurements) would have been used during the development and training phases as well.

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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 Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (CCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.

The user is not intended to take medical action based on the device output without consultation with a qualified healtheare professional.

The Stelo Glucose Biosensor system (Stelo System) is an over-the-counter (OTC) interoperable continuous glucose monitoring (iCGM) system.

The Stelo Glucose Biosensor system (Stelo System) is an interoperable connected device that measures and displays estimated glucose values for people who are not on insulin. The Stelo System consists of the following components: the Glucose Sensing Subsystem (GSS) and the Mobile Application Subsystem (MAS). 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 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 is an app that can be downloaded to a compatible smart device and that presents glucose readings and qlucose trend to the user every 15 minutes. As such, the most recent displayed glucose value might be up to 15 minutes old. Each sensor session lasts up to 15 days with an extended 12-hour grace period. The grace period allows additional time for the user to change the sensor at a convenient time.

The proposed Stelo System is based on the same mode of operation and mechanism of reaction as the predicate G7 CGM System (K231081), which uses a wire type sensing mechanism that continuously measures interstitial fluid qlucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, excluding insulin pens and Automated Insulin Dosing (AID) systems.

The Stelo System uses the same hardware design as the predicate G7 CGM System. The Stelo GSS firmware is designed to support a factory-calibrated only device (without calibration inputs), to extend the sensor wear duration from 10 to 15 days while maintaining the accuracy of the device, and to connect to authorized display devices only (i.e., Stelo MAS). The Stelo MAS includes a redesigned user interface (UI) tailored to the Stelo System's user population to simplify the use of the device. The UI includes an app onboarding specific to the Stelo MAS design and its intended use, the most recent glucose value and trend graph which are updated every 15 minutes, a narrowed glucose range display from 70 mg/dL, and an "Insights" feature providing the time in range percentage with suggestions to help users improve their time in range. The Ul does not provide any glucose or system alerts.

The Dexcom Stelo Glucose Biosensor System is a continuous glucose monitoring (CGM) device intended for over-the-counter (OTC) use by adults aged 18 and older who are not on insulin. The device continuously measures, records, and displays glucose values, helping to detect normal, low, or high glucose levels and allowing users to understand the impact of lifestyle modifications on glucose excursion.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. While specific numerical acceptance criteria (e.g., MARD values, percentages of readings within certain zones) are not provided in the summary, the general umbrella acceptance criterion is:

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

The document states: "A clinical study was conducted to evaluate the safety and effectiveness of the Stelo Glucose Biosensor System. The effectiveness of the device was evaluated with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration with a 12-hour grace period in adult (18 years and older) participants with diabetes."

• Test Set Sample Size: The exact number of participants is not specified, but it refers to "adult (18 years and older) participants with diabetes."
• Data Provenance: Prospective clinical study data. The country of origin is not explicitly stated in the provided text.

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

The ground truth for the clinical study was established using "reference venous plasma sample YSI measurements." This usually refers to laboratory-based glucose analysis performed by trained technicians, not "experts" in the context of interpretation (like radiologists). The number and qualifications of technicians are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth was established through laboratory reference measurements (YSI) of venous plasma samples, which are generally considered the gold standard and do not typically require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study evaluated the standalone performance of the Stelo Glucose Biosensor System against reference measurements. The document does not mention any human readers or human-AI interaction in the context of this study.

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

Yes, a standalone study was done. The clinical study evaluated the Stelo Glucose Biosensor System's effectiveness by comparing its glucose measurements to reference venous plasma YSI measurements, implying an assessment of the device's algorithmic and sensing accuracy without human intervention for interpretation beyond what the user does with the displayed values.

7. The Type of Ground Truth Used:

The ground truth used was laboratory reference measurements ("reference venous plasma sample YSI measurements").

8. The Sample Size for the Training Set:

The document does not provide any information about the training set size for the algorithms within the Stelo Glucose Biosensor System. This information is typically not included in a 510(k) summary unless the submission is for an AI/ML SaMD where the training data characteristics are a primary focus. Given that the Stelo System uses the "same hardware design as the predicate G7 CGM System" and its GSS firmware is designed to support a "factory-calibrated only device (without calibration inputs)," it suggests that the core algorithms might have been trained previously and validated, or leveraged from the predicate device's development.

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

This information is not provided in the document.

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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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