(25 days)
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow mobile application.
The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.
This is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. The manufacturer, Dexcom, Inc., is seeking to market a device that is substantially equivalent to a legally marketed predicate device. The primary change in the new device is the inclusion of an alternative, ultrasonic-welded transmitter.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a table of acceptance criteria and reported device performance in the format of a clinical study summary with specific numerical endpoints and their corresponding achieved values. Instead, it states that:
"The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled."
This implies that the acceptance criteria are met through verification and validation activities aligned with the stated standards and internal processes, but the specific performance metrics (e.g., MARD, accuracy at different glucose levels) are not detailed in this summary. The substantial equivalence argument relies on the fact that the hardware change (transmitter) does not impact the core performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described focuses on "performance testing and software verification and validation testing" for the new transmitter and "system integration testing" with the existing mobile app. This suggests technical validation rather than a clinical trial with a patient test set for performance comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Given the nature of a Continuous Glucose Monitoring (CGM) system, the "ground truth" for glucose measurements is typically established using a laboratory reference method (e.g., YSI analyzer for blood glucose), not expert consensus from medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. This type of adjudication is typically used in clinical studies where expert review is required for endpoints, which is not directly applicable to the performance evaluation of a CGM system's glucose readings in the same way as, for example, image interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. The Dexcom G6 is a Continuous Glucose Monitoring system that provides direct glucose readings and trends; it is not an AI-assisted diagnostic device that requires human interpretation in the same manner as a radiological imaging system. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the core performance of the Dexcom G6 system, which includes the algorithm's ability to convert sensor signals into glucose readings, is fundamentally a standalone (algorithm only) performance evaluation. The document states: "The proposed Dexcom G6 Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction." and "The transmitter... converts these measurements into glucose readings using an onboard algorithm." The "performance testing" mentioned validates this standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated in this summary, for Continuous Glucose Monitoring (CGM) systems, the ground truth for performance testing (e.g., accuracy against reference values) is typically established by laboratory reference methods for blood glucose, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.
8. The sample size for the training set
The document does not provide information on the sample size for the training set. This is a 510(k) submission for a modification (new transmitter) to an already cleared device, not an initial submission for a novel algorithm where training set details would be more prominently discussed. The original Dexcom G6 system would have undergone extensive training and validation.
9. How the ground truth for the training set was established
The document does not provide details on how the ground truth for the training set was established. Similar to the test set, it would have involved laboratory reference methods for glucose measurement during the development of the original Dexcom G6 algorithm.
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.