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The Dexcom G6 Continuous Glucose Monitoring 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 sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes of hyperglycemia, 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 proposed Dexcom G6 CGM System is based on the same physical principles and fundamental design as the predicate but includes an alternative receiver. This receiver has identical hardware to the G7 receiver (K213919). The Dexcom G6 CGM System is designed to function as intended with either the proposed or current commercial receiver. The proposed receiver has the same function as the commercial receiver.

The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts ducose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current qlucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices.

Based on the provided text, the acceptance criteria and study details for the Dexcom G6 Continuous Glucose Monitoring (CGM) System are not explicitly detailed in a table format with specific performance metrics. This document primarily focuses on demonstrating substantial equivalence to a predicate device, K221259, rather than presenting a comprehensive clinical performance study.

However, I can infer some information based on the context:

Acceptance Criteria and Reported Device Performance

The document states that the proposed Dexcom G6 CGM System performs "according to specifications and meets the technological and performance criteria which have not changed from the predicate device." This implies that the acceptance criteria for the new device are the same as those established for the predicate device (Dexcom G6 CGM System, K221259). Since the core components (sensor, applicator, transmitter, and app requirements) are the same, the performance is expected to be identical to the predicate.

While quantitative acceptance criteria are not explicitly listed in this document, for CGM devices, such criteria typically relate to accuracy, precision, and reliability of glucose measurements compared to a reference method (e.g., YSI analyzer for blood glucose). The predicate device would have met specific MARD (Mean Absolute Relative Difference) targets and operated within defined accuracy zones (e.g., Consensus Error Grid Analysis).

Inferred Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:
   The document states: "Therefore, performance testing and software verification and validation testing completed for the predicate device (K221259) remain applicable." This indicates that the performance data used to demonstrate safety and effectiveness for this specific submission (K223931) is largely derived from the studies conducted for the predicate device (K221259). As such, the sample size and data provenance for the predicate device's original studies would be relevant, but are not provided in this document. For K223931, the testing specifically focused on the new receiver.

   • No specific sample size for a test set is provided within this document for K223931.
   • Data provenance for K223931's specific testing of the new receiver is not described (e.g., country of origin, retrospective/prospective). It mentions "firmware and hardware testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The ground truth for CGM studies typically involves laboratory reference methods (e.g., YSI blood glucose measurements), not expert consensus in the same way as imaging studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not provided in the document. Adjudication methods are not typically applicable to CGM device performance studies, as ground truth is established through a quantitative laboratory reference method.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging where human readers interpret results, often with and without AI assistance. For a CGM device, the performance is measured against a quantitative reference method, not human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Yes, implicitly. The core of a CGM system's performance, particularly its accuracy (MARD, CEGA), is essentially a standalone (algorithm-only) assessment, as the device's algorithm generates the glucose values. The document states the "Glucose Value Estimation Algorithm" is a "Joint Probability Algorithm" which is the "Same" as the predicate. The performance testing for the predicate would have covered this standalone aspect.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   While not explicitly stated for K223931, CGM studies generally use laboratory reference blood glucose measurements (e.g., YSI glucose analyzer) as the ground truth. This is the standard for evaluating the accuracy of glucose monitoring devices.

7. The sample size for the training set:
   The document does not provide information regarding the sample size for the training set. Since the "Glucose Value Estimation Algorithm" is the "Same" as the predicate device, it implies that the algorithm was trained using data collected for the development of the original G6 system.

8. How the ground truth for the training set was established:
   The document does not provide information on how the ground truth for the training set was established. However, similar to the test set, it would typically be established using laboratory reference blood glucose measurements during the development and training phases of the original Dexcom G6 system's algorithm.

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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 hypoqlycemia, 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 2 years and older.

The Dexcom Glucose Program System is intended to replace fingerstick blood ducose 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 G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood qlucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.

The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.

The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in coniunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.

The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are based on the same physical principles and fundamental design as the predicate for each respective system but includes a modified adhesive patch. The adhesive patch adheres the transmitter holder to the user's body. The Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and the Dexcom G6 Professional CGM 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.

Dexcom G6 CGM System: The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). 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 time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) 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. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices.

Dexcom G6 Glucose Program CGM System: The Dexcom G6 Glucose Program Continuous Glucose Monitoring System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous qlucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a mobile CGM software module (app module) that is embedded within a third-party program provider's mobile app (host app).

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 is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the app module, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The app module does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.

Dexcom G6 Professional CGM System: The Dexcom G6 Professional CGM System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM.

The G6 Professional CGM 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 G6 Professional CGM System 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 G6 Professional CGM System transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Professional CGM System transmitter can be used as a retrospective CGM data logger, and it can also send real-time estimated glucose values to the G6 Mobile Application. The HCP elects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Professional CGM System transmitter firmware supports a single-use 10-day sensor session per transmitter. The G6 Mobile Application displays the current glucose reading (updated every 5 minutes) and qlucose trends (up to 24 hours) from the transmitter.

This document, a 510(k) Premarket Notification from the FDA, details the equivalence of several Dexcom G6 Continuous Glucose Monitoring (CGM) Systems to previously cleared predicate devices. The core change in the subject devices compared to their predicates is a modified adhesive patch.

Therefore, the acceptance criteria and study proving the device meets these criteria would primarily relate to the performance of the device with this new adhesive patch, demonstrating it does not adversely affect the system's safety and effectiveness.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document states that the proposed devices performed "according to their respective specifications" and "met their technological and performance criteria which have not changed from the predicate devices." Because the submission is based on substantial equivalence due to a minor change (adhesive patch), specific performance metrics and their acceptance criteria are not explicitly detailed in this summary; rather, the underlying assumption is that the performance remains consistent with the already-cleared predicates.

Therefore, the table would look like this:

For a CGM system, typical performance metrics would include:

• Accuracy (e.g., MARD - Mean Absolute Relative Difference): How close the CGM readings are to reference blood glucose values.
• Time in Range (TIR): Percentage of time glucose readings are within a target range.
• Detection of Hypo/Hyperglycemia: Ability to accurately identify low and high glucose events.
• Sensor Wear Time: The specified duration the sensor can be worn (stated as up to 10 days).
• Alarm/Alert Performance (where applicable): Timeliness and accuracy of alerts.
• Adhesion Performance: Ensuring the new patch maintains the sensor on the body for the intended wear time without causing adverse skin reactions.

However, these specific quantitative criteria are not provided in this 510(k) summary, as the submission focuses on the impact of the adhesive patch change.

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 mentions that the devices "were verified and validated according to Dexcom's internal design control process." It does not provide explicit details about the sample sizes used in the testing or the specific provenance of the data (country of origin, retrospective/prospective). This level of detail is typically found in the full 510(k) submission, not the summary.

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 CGM systems, the "ground truth" for glucose values is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer) for blood samples, rather than human expert consensus, as it's a quantitative measurement.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as it's not relevant for device performance evaluation of a CGM system based on quantitative measurements against a reference. Adjudication methods like 2+1 or 3+1 are common in diagnostic image interpretation studies where human expert consensus on image findings serves as ground truth.

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

An MRMC study is relevant for AI-assisted image interpretation. This document describes a Continuous Glucose Monitoring (CGM) system, which is a sensor-based medical device that measures glucose levels directly. It is not an AI-assisted diagnostic imaging device, and therefore, an MRMC comparative effectiveness study would not be applicable or performed for this device.

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

For a CGM system, the device (sensor + transmitter + algorithm) generates glucose values autonomously. The "human-in-the-loop" is the user who interprets these values for diabetes management. The system is inherently designed to provide standalone glucose readings. The "Estimated Glucose Value (EGV) using an onboard algorithm" indicates standalone algorithmic performance. The document states: "Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time" and the system "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments."

This confirms that the algorithm provides direct, actionable results, and its performance is evaluated as a standalone system generating glucose values.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a CGM system is typically established by concurrent blood glucose measurements obtained using a highly accurate laboratory reference method (e.g., YSI glucose analyzer) from venous blood draws. While not explicitly stated in this summary, this is the standard for CGM validation. The device's "Estimated Glucose Values (EGV)" are compared against these laboratory reference values.

8. The sample size for the training set

This document describes a 510(k) submission for a device change (adhesive patch) to existing, cleared devices. The core algorithms (e.g., "Joint Probability Algorithm") are already established and cleared from prior submissions (the predicates). Therefore, specific training set information for the algorithms themselves is not detailed here, as the algorithms are not being fundamentally changed or retrained. The testing mentioned in this document (verification and validation) would be focused on demonstrating that the new adhesive patch does not negatively impact the already-established performance of the system.

9. How the ground truth for the training set was established

As in point 8, the algorithms are inherited from previously cleared devices. For the original development of these algorithms, the ground truth would have been established through extensive clinical studies involving human subjects, where CGM readings were compared against simultaneous, high-accuracy laboratory reference blood glucose measurements. The process would involve collecting paired data points (CGM reading and reference blood glucose) across a wide range of glucose values, physiological states, and patient populations.

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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 sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia, 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 Continuous Glucose Monitoring System (G6 System) is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). 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 time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) 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. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 System is designed to be used alone or in conjunction with digitally connected devices. The G6 System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices in several ways, such as described below:

• 1. Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
• 2. The app communicates to another app on a single mobile platform.
• 3. The app communicates through the cloud to another software device.

The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K200876), but it includes an additional software component.

The added software component, which consists of cloud-based Application Programming Interfaces (APIs), is identified as Dexcom Partner Web APIs (Partner Web APIs). The Partner Web APIs enables communication of iCGM data to client software intended to receive the data through the cloud. The transmitted data can be used by authorized client software for specific and permitted use cases including non-medical device application, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. The software application may not be used in environments not currently cleared for Dexcom G6 CGM System (e.g. hospital for inpatient care). The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Dexcom display devices (receiver and mobile app) continues to serve as a primary display device for the (iCGM) data, which directly receives the data from the transmitter. Identical to the G6 CGM System cleared in K200876, the mobile app includes a design mitigation that overrides Do Not Disturb settings on the smart device with the users' consent. With this app design mitigation, the G6 CGM system functions as intended to provide users with critical alarm and alerts (e.g. Urgent Low alarm) regardless of the user's smart device settings for Do Not Disturb. The current components of the Dexcom G6 System (sensor/applicator, transmitter, and display devices) have not been changed as a result of the added Partner Web APIs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dexcom G6 Continuous Glucose Monitoring System (K201328):

*The provided document is primarily a 510(k) summary for a premarket notification to the FDA. It does not contain specific details about acceptance criteria and the comprehensive study that proves the device meets those criteria, particularly the clinical performance data often found in a full submission. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K2008776) due to an added software component.

Therefore, many of your requested points cannot be fully addressed from the given text. I will provide information where available and note when it is not present.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance for K201328. It states that the proposed system's technological and performance criteria have not changed from the predicate device (K2008776).

However, it implicitly relies on the performance of the predicate device. For a typical CGM, acceptance criteria would include metrics like:

• Accuracy (MARD - Mean Absolute Relative Difference): A measure of how close the CGM readings are to a reference blood glucose measurement.
• Accuracy (Consensus Error Grid Analysis): A visual representation of clinical accuracy, indicating how many CGM readings fall within clinically acceptable zones compared to reference values.
• Alert Performance: Accuracy of hyperglycemia/hypoglycemia alerts.
• Operating Conditions: Performance across various blood glucose levels, temperature, and wear time.

Since the submission is for an added software component (cloud-based APIs) to an already cleared device, the core clinical performance (e.g., MARD) is assumed to be carried over from the predicate. The "performance testing" mentioned in the document focuses on the new software component's specifications.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document for the core CGM functionality, as it defers to the predicate device's performance.

The document does state that the added software component's own performance criteria were met:

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance:

   • Not explicitly stated in this document. The document refers to "software verification" for the new component. For the underlying CGM performance (which is attributed to the predicate), this information would be in the predicate's 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not stated. This type of information is typically for studies involving human interpretation (e.g., imaging studies). The Dexcom G6 is an automated glucose measurement device. Its "ground truth" would be established by a laboratory reference method, not expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not stated. See point 2.

4. 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:

   • Not applicable. The Dexcom G6 is a continuous glucose monitoring system, not an AI-assisted diagnostic imaging device that requires human "readers." The "AI" would be the algorithm that processes raw sensor data into glucose values.

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

   • Yes, implicitly. The Dexcom G6 CGM system, by its nature, is a standalone device that measures glucose values algorithmically. The "human-in-the-loop" refers to the user observing the displayed values and trends. The core performance data (MARD, etc.) typically evaluates the algorithm's accuracy against a lab reference. The current submission focuses on the communication of these algorithmically derived values.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For glucose monitoring devices, the ground truth is typically established using a laboratory reference method for blood glucose measurement (e.g., YSI analyzer, hexokinase method). The document refers to "estimated glucose values (EGV)" generated by an "onboard algorithm" compared to which the system's accuracy would be assessed.

7. The sample size for the training set:

   • Not stated in this document. The document describes an "onboard algorithm" for converting sensor data to glucose values, which would have been developed and trained using a dataset. This information would be part of the original K2008776 submission, not this update.

8. How the ground truth for the training set was established:

   • Not stated in this document, but inferred to be laboratory reference methods. Similar to the test set ground truth, the training data for the internal algorithm would have been paired with accurate laboratory blood glucose measurements.

In summary, this 510(k) submission (K201328) is for a modification (added software component, Partner Web APIs) to an already cleared device (K2008776). Therefore, it largely emphasizes the substantial equivalence of the modified device to its predicate, particularly regarding the core glucose monitoring functionality. The explicit details about the original clinical performance study (acceptance criteria, sample sizes, ground truth methodology) for the glucose measurement itself are not provided in this document but are presumed to be part of the predicate's submission.

The performance testing mentioned in this document (Section 5.8, "Summary of Performance Testing") specifically refers to software verification of the new cloud-based API component, ensuring it meets its specifications for data confidentiality, integrity, and timely availability.

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