Search Results

The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater.

Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for single patient use and requires a prescription

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi mobile application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set.

The Tandem Mobi mobile application ("mobile app") displays all information from, and is the primary controller of, the pump. Through the mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi mobile application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi mobile application will be made available via the Android Play® App store for Android-compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

N/A

Ask a specific question about this device

The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription.

The pump is indicated for use in individuals six years of age and greater.

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the t:connect mobile app and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The t:connect mobile app ("Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications and messages. The t:connect mobile app will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:connect mobile app will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.

This document K233044 is a 510(k) premarket notification for the Tandem Mobi insulin pump with interoperable technology. It is a "Special 510(k)" submission, which means it relies on a previously cleared predicate device (K223213) to demonstrate substantial equivalence, rather than providing entirely new data.

Therefore, the document explicitly states that "No new clinical testing was performed to support this 510(k) Notification." This means that the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document, as the submission relies on the prior clearance of the predicate device.

Based on the provided text, I cannot provide the details you requested because the submission is a Special 510(k) and explicitly states that no new performance testing (including clinical, usability, software, electrical safety, or biocompatibility) was performed.

The relevant sections that confirm this are:

• "IV. Overview of Non-Clinical Performance Tests"
  • "Usability/Human Factors: No new Usability or Human Factors testing was performed to support this 510(k) Notification."
  • "Software Verification and Validation: No new Software testing was performed to support this 510(k) Notification."
  • "Electrical Safety/ EMC: No new Electrical and Electromagnetic Compatibility (EMC) was performed to support this 510(k) Notification."
  • "Insulin Compatibility and Biocompatibility: No new insulin compatibility testing was performed to support this 510(k) Notification."
  • "Clinical Testing: No new clinical testing was performed to support this 510(k) Notification."
• "Conclusion: The Subject Device serves the same function as the Predicate Device. Furthermore, the Subject Device performs insulin therapy functions that are the same as that of the Predicate Device. The required technical documentation provided in this Special 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness."

To get the information you requested, one would need to review the original 510(k) submission for the predicate device (K223213), as that would presumably contain the "new" testing data that established its safety and effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on this K233044 document.

Ask a specific question about this device

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.

Ask a specific question about this device

Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 14 years of age and greater.

Control-IQ technology is intended for single patient use and requires a prescription.

Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

Control-IQ technology (Control-IQ, the device) is a software-only device intended for use by people with diabetes. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ technology is meant to be installed on a compatible ACE pump.

Control-IQ technology works to control glucose towards a glucose target range of 112.5-160 mg/dL during normal use. Glucose targets are not customizable but can be changed by a user if sleep or exercise modes are set or announced. During sleep mode, this range is changed to 112.5-120 mg/dL, and it is changed to 140-160 mg/dL during exercise mode.

Control-IQ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when the Control-IO technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.

Using Control-IQ technology requires that users input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.

Acceptance Criteria and Device Performance for Control-IQ Technology

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for outcomes like HbA1c, Time in Range, or adverse event rates. Instead, the "Performance Characteristics" section reports the observed results of the pivotal study, which are then analyzed in the "Benefit/Risk Analysis" to generally conclude that the device's benefits outweigh its risks in light of the special controls.

However, based on the implicit goals of the study and the reported findings, we can infer some criteria that the device's performance needed to satisfy to be considered acceptable for De Novo authorization. These inferred criteria are focused on demonstrating improvements in glycemic control without an unacceptable increase in adverse events compared to the control arm (Sensor-augmented pump - SAP).

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

• Test Set Sample Size: The pivotal clinical study (randomization phase) included 168 participants, with 112 in the intervention arm (Control-IQ) and 56 in the control arm (Sensor-augmented pump - SAP). The study involved 6 months of follow-up for the primary study.
• Data Provenance: The study was a prospective, multicenter clinical trial conducted at Seven US clinical sites. The participants were diagnosed with Type 1 Diabetes and were aged 14 years and older.

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

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, the clinical study directly measured physiological outcomes (CGM readings, HbA1c, adverse events) from the participants. These are considered the objective "ground truth" data for assessing the device's performance in managing diabetes.

Healthcare providers were involved in training participants and optimizing pump settings, and monitoring participants for adverse events, but not for establishing a separate "ground truth" label for individual data points that the algorithm would then predict against.

4. Adjudication Method for the Test Set

As the test set involved direct physiological measurements and reported adverse events, a formal adjudication method like "2+1" or "3+1" (common in image-based diagnostic studies) is not applicable in the same way.

Adverse events were reported and summarized. The document mentions an evaluation of hyperglycemia/ketosis events:

• "Hyperglycemia / ketosis events not meeting the definition of DKA were reportable if they met one of the following criteria: evaluation or treatment was obtained at a health care provider facility... blood ketone level ≥1.0 mmol/L and communication occurred with a health care provider... blood ketone level ≥3.0 mmol/L, even if there was no communication with a health care provider."
• This indicates predefined criteria for event reporting rather than an external expert adjudication process of subjective assessments. The DKA event was noted as having an "infusion set failure" as its cause, implying a clinical assessment of the event's origin.

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

No, an MRMC comparative effectiveness study was not explicitly conducted or mentioned. This type of study is more relevant for diagnostic devices where human readers interpret patient cases (e.g., images) with and without AI assistance. The Control-IQ device is an automated insulin delivery system, directly affecting physiological outcomes rather than assisting a human in making a diagnostic interpretation.

6. Standalone (Algorithm Only) Performance

Yes, the pivotal clinical study assessed the standalone performance of the Control-IQ technology. The intervention arm used "t:slim X2 with Control-IQ Technology and Dexcom G6 iCGM" (closed-loop control), representing the algorithm's performance without direct continuous human intervention in real-time insulin dosing decisions (though users still manually entered meal boluses and could adjust settings). The control arm (Sensor-augmented pump - SAP, with no automated insulin delivery) provided a baseline for comparison for human-managed delivery using similar sensor data.

The "Safety of CGM Auto-populating Bolus Calculator Feature" section also analyzes the performance when the iCGM values are "Automatic" (meaning auto-populated by the device) versus "Manual" (meaning patients manually adjusted the bolus calculation), providing insights into a more granular standalone feature compared to human override.

7. Type of Ground Truth Used

The ground truth used in the pivotal study was outcomes data directly measured from participants, including:

• Continuous Glucose Monitoring (CGM) readings (e.g., Time in Range, Time Below Range, Mean Glucose).
• HbA1c levels (a measure of average blood glucose over 2-3 months).
• Reported adverse events (severe hypoglycemia, DKA, hyperglycemia/ketosis).
• Surveys on quality of life aspects (diabetes-related distress and fear of hypoglycemia).

8. Sample Size for the Training Set

The document does not provide information on a separate "training set" sample size for the Control-IQ algorithm itself. Control-IQ is a software-only device containing a proprietary algorithm. Generally, such algorithms are developed and refined using a combination of preclinical modeling, simulations, and smaller-scale human studies, which would constitute the "training" or development sets. However, the exact size and nature of this development data are not detailed in this regulatory document, which focuses on the pivotal clinical validation study.

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

As with the training set sample size, the document does not describe how ground truth was established for any internal algorithm training set. For an automated insulin delivery algorithm, the ground truth for training would typically involve physiological responses to insulin in people with diabetes, potentially derived from historical patient data, controlled meal challenges, exercise protocols, and various other scenarios, often simulated or collected under tightly controlled observational studies. The goal is to build a model that accurately predicts glucose responses to insulin and other physiological factors.

Ask a specific question about this device

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 Continuous Glucose Monitoring 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 Dexcom 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 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter. The proposed Dexcom G6 System is based on the same physical principles and fundamental design as the commercially-available Dexcom G6 System (DEN170088), but has modifications to physical design, software, and hardware of the transmitter. The Dexcom G6 System is designed to function as intended with either the proposed, or current G6 transmitter. The proposed G6 transmitter has the same form, fit, and function as the commercial G6 transmitter and, from the users' perspective, functions identically.

This document is an FDA 510(k) premarket notification for the Dexcom G6 Continuous Glucose Monitoring System, focusing on a modification to the transmitter. It does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study. Therefore, some of the requested information, particularly quantitative results and specific methodologies for establishing ground truth, cannot be extracted from this document.

However, based on the provided text, here's what can be gathered:

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

The document states that the proposed Dexcom G6 System meets all required performance criteria for the predicate Dexcom G6 System. However, the specific acceptance criteria and the quantitative performance metrics (e.g., MARD, accuracy at different glucose ranges) are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. The document only states that the device was "verified and validated" through performance testing.

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 summary. For continuous glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) measuring blood glucose, not by expert review in the same way it would be for imaging diagnostics.

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

This information is not provided in the summary. Adjudication is not typically applicable in the same way for CGM performance testing where objective measurements are compared against a reference.

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 here. This device is a continuous glucose monitoring system, not an AI-assisted diagnostic imaging tool that involves human readers.

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

Yes, the performance testing for a CGM system fundamentally assesses the standalone algorithm and hardware performance in measuring and reporting glucose levels. The document states: "The proposed Dexcom G6 System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device." While human users interact with the device, the core performance evaluation concerns the accuracy of the glucose readings generated by the system itself.

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

For continuous glucose monitoring systems, the ground truth is typically established by laboratory reference methods to measure blood glucose concentrations. The document does not explicitly state the method, but this is the standard for CGM validation.

8. The sample size for the training set

This information is not provided in the summary. The document describes modifications to an existing device (Dexcom G6, DEN170088) that already had its algorithm developed and validated. The current submission focuses on a new transmitter design, implying that the core algorithm trained on previous data remains largely unchanged ("The Dexcom G6 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter").

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

This information is not provided in the summary, as the training set details for the original Dexcom G6 algorithm are not within the scope of this particular submission for a transmitter modification. However, as with point 7, it would typically involve laboratory reference methods for blood glucose determination.

Ask a specific question about this device

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.

Ask a specific question about this device