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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 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 Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the predicate Dexcom G6 CGM System.

The Dexcom Pro Q System consists of two main components: 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).

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided document is a 510(k) summary for the Dexcom Pro Q Continuous Glucose Monitoring System, comparing it to the Dexcom G6 CGM System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive new clinical studies for efficacy. Therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a novel clinical trial with specific performance endpoints outlined in detail isn't fully present in this document. Instead, it relies on the predicate's established performance and verifies that the new device performs similarly.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a typical table format for a clinical study. Instead, it claims substantial equivalence to the predicate device (Dexcom G6), which implies that its performance should be comparable. The relevant performance claims are related to its function as a continuous glucose recording device for retrospective analysis.

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

The document does not provide details on the sample size for a test set for the Dexcom Pro Q, nor does it specify data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission not requiring new clinical trials, as it relies on the predicate's established performance and the new device's verification against its own specifications. The "performance testing" mentioned is likely internal validation and verification processes rather than a new clinical study with a distinct test set.

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

This information is not provided. Given the nature of a 510(k) submission based on substantial equivalence and typical device verification/validation, a panel of experts for ground truth establishment in a clinical context isn't a stated component of the testing summarized here. Ground truth would be based on reference glucose measurements if any clinical data was collected, but details are absent.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method.

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

No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical factor. For a CGM device, the primary "output" is a glucose value, not an interpretation by a reader.

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

The document heavily implies standalone algorithm performance as a core component of its functioning. The "transmitter samples the electrical current... and converts these measurements into glucose readings using an onboard algorithm" (Page 4). The "performance testing" mentioned in Section 5.7 would have verified the accuracy of this algorithm against specified targets, although the specifics of the test protocol are not provided in this summary.

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated in this summary. For CGM devices, the ground truth for glucose values would typically be obtained from a highly accurate laboratory reference method (e.g., YSI glucose analyzer) applied to blood samples taken simultaneously with CGM readings. This would be part of the predicate device's original clinical validation. For the Dexcom Pro Q, if any new clinical data were collected, similar reference methods would be used.

8. The Sample Size for the Training Set

The document does not provide information about the training set size for the algorithm. It states the Dexcom Pro Q System uses an "onboard algorithm" but doesn't detail its development or training.

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

This information is not provided. Similar to point 8, the document is a 510(k) summary focused on substantial equivalence rather than a detailed algorithm development document.

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