Search Results

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.

Ask a specific question about this device