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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 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, Control-IQ+ technology ("Control-IQ+") is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. 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 by 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 has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During Normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 – 160 mg/dL, during Sleep mode the target range is 112.5 – 120 mg/dL, and during Exercise mode the target range is 140 – 160 mg/dL.

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

Control-IQ+ technology requires users to 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.

This FDA 510(k) clearance letter describes the acceptance criteria and study for the Control-IQ+ technology, an interoperable automated glycemic controller.

It's important to note that this device is a software-only device (Control-IQ+ technology), and the primary change described in this 510(k) is the addition of a new compatible insulin (Lyumjev U-100 Insulin) for use with the existing Control-IQ technology. The clearance relies heavily on the substantial equivalence to a predicate device (K243823, Control-IQ+ technology) and a clinical study demonstrating the safety and effectiveness of the new compatible insulin with the existing Control-IQ system.

Here's the breakdown of the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" for the Control-IQ+ technology's performance in terms of glucose control metrics (e.g., time in range, hypoglycemia rates) for this specific 510(k) submission. Instead, the "acceptance" for this submission appears to be based on demonstrating non-inferiority or better safety when using the new insulin (Lyumjev) with the already cleared Control-IQ system, compared to established benchmarks.

The primary "performance" mentioned is related to safety, specifically the rates of severe hypoglycemia and DKA.

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

• Sample Size: 179 participants with type 1 diabetes.
  • 70 adults (18-75 years old)
  • 109 pediatric participants (6-17 years old)
• Data Provenance: The study was a "single-arm prospective safety trial." While the exact country of origin isn't specified, FDA clearances typically involve studies conducted in the US or under protocols recognized by the FDA. The T1D Exchange clinic registry is a US-based registry, suggesting a likely US context for the study.
• Retrospective/Prospective: Prospective. The study involved an initial (~16-day) Humalog Lead-in Period and a subsequent (13-week) Lyumjev Treatment Period.

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

This type of device (automated glycemic controller) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic AI might. The "ground truth" for glucose control is direct physiological measurements (iCGM readings) and clinical outcomes (hypoglycemia, DKA). Therefore, specific numbers or qualifications of experts for establishing ground truth are not applicable in this context. The study design itself serves to establish the performance and safety against clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective expert interpretation of data (e.g., radiologists reviewing images). For a system controlling insulin delivery based on CGM data, adjudication of such a type is not applicable. Clinical events (severe hypoglycemia, DKA) are typically adjudicated by an independent clinical endpoint committee or medical monitors based on predefined criteria, but the document does not specify this level of detail.

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

No, an MRMC comparative effectiveness study was not done.
MRMC studies are relevant for diagnostic aids where human readers interpret data (e.g., images) with and without AI assistance to measure improvement in reader performance. Control-IQ+ technology directly controls insulin delivery; it is not an assistive diagnostic tool for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The device is an "Interoperable Automated Glycemic Controller," meaning it operates to "automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values." It also delivers "correction boluses." This indicates that the core function is standalone (algorithm-only) in its closed-loop operation. While users can input data (carbohydrate intake, exercise, sleep schedule) and the device is intended for "single patient use" with a "prescription," the control logic itself functions automatically without continuous human intervention in real-time decision-making for insulin delivery adjustment. The study evaluates the system performance which includes this automated functionality.

7. The Type of Ground Truth Used

The ground truth used for this study was primarily:

• Physiological data: iCGM readings for glucose values.
• Clinical Outcomes Data: Rates of severe hypoglycemia and DKA events. These were compared against "reported frequencies from the T1D Exchange clinic registry" as a benchmark for safety.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set of the Control-IQ+ technology. This 510(k) is for a modification (new compatible insulin) to an already cleared device, implying the core algorithm was trained and validated previously.

9. 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 of the original Control-IQ algorithm was established. Given the nature of an automated glycemic controller, it would typically involve extensive simulations, in-silico testing, and potentially prior clinical trials where continuous glucose monitoring (CGM) data, insulin delivery data, and corresponding blood glucose measurements were collected and used to train and validate the control algorithms. However, this specific 510(k) submission focuses on the safety and effectiveness of a new component (Lyumjev insulin) with the existing system rather than the initial foundational algorithm development.

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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 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.

Control-IQ+ technology (Control-IQ+, the device) is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. 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 by 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 has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 - 160 mg/dL. 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 Control-IQ + technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.

Control-IQ+ technology requires users to 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.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them, presented in the requested format.

It's important to note that the provided text is an FDA 510(k) clearance letter and a 510(k) summary. These documents primarily focus on demonstrating substantial equivalence to a predicate device, rather than providing a detailed technical breakdown of novel acceptance criteria for algorithm performance in the same way one might expect for a new AI/ML device where performance metrics (e.g., sensitivity, specificity, accuracy) are the primary basis of clearance.

For Control-IQ+ technology, the key change is the expansion of the intended use to include Type 2 diabetes patients, supported by a pivotal clinical study. The algorithm itself is stated to be "unchanged," implying that its core performance characteristics (e.g., glucose control targets, basal rate adjustments) are those already established for Type 1 diabetes with the predicate device. Therefore, the "acceptance criteria" here largely pertain to the clinical safety and effectiveness in the new population, rather than the internal algorithmic performance metrics.

Acceptance Criteria and Device Performance Study for Control-IQ+ Technology

Given that the device is a refined version of an already cleared product ("Control-IQ technology" K232382) and the core algorithm is "unchanged," the acceptance criteria for this 510(k) submission (K243823) are primarily focused on demonstrating the safety and effectiveness of expanding its indications to include Type 2 diabetes patients. The primary evidence for this is a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) focusing on an expanded user population for an existing algorithm rather than a de novo submission for a novel AI algorithm with specific performance cutoffs, the acceptance criteria are framed in terms of clinical outcomes rather than typical AI performance metrics like sensitivity/specificity.

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

• Test Set (Clinical Study):
  • Sample Size: 319 subjects
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies a multi-site prospective clinical trial. The study was a "randomized controlled trial."
  • Retrospective/Prospective: Prospective

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

This information is not provided in the document. For a clinical trial of an automated glycemic controller, the "ground truth" for evaluating effectiveness is typically objective clinical measurements (e.g., HbA1C tests, CGM data, adverse events) rather than expert consensus on diagnostic images. Clinical outcomes are inherently the "ground truth." Expert physicians would design the trial, manage patients, and interpret results, but they aren't establishing a "ground truth" per se in the way radiologists might do for disease detection.

4. Adjudication Method for the Test Set

This information is not provided. For a randomized controlled trial measuring objective metrics like HbA1C, formal adjudication in the sense of a diagnostic agreement (e.g., 2+1 radiology consensus) is generally not applicable, as the outcomes are quantitative and measured directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI, where human readers (e.g., radiologists) interpret images with or without AI assistance.
• Effect Size of Human Improvement with AI: Not applicable, as this device is an automated glycemic controller, not an AI assisting human interpretation of medical images. The clinical study compares the device's performance directly against a control group (CGM with continued insulin injections), rather than evaluating human reader performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• The "Clinical Testing" section describes a pivotal clinical study where Control-IQ+ technology's performance (an automated insulin delivery system) was evaluated in patients. While it's implied that the system operates autonomously based on CGM inputs and user settings, the study measures the system's performance in a real-world setting with human users interacting with the device, not a purely standalone algorithmic evaluation in a simulated environment. The study is effectively evaluating the device's performance as intended for clinical use.

7. The Type of Ground Truth Used

• The primary ground truth for the clinical study was outcomes data, specifically the change in HbA1C (Glycated Hemoglobin), which is a key clinical endpoint for diabetes management. Other clinical measures from the iCGM (e.g., glucose values, time in range) and safety outcomes would also serve as ground truth for evaluating the device's performance.

8. The Sample Size for the Training Set

• This information is not provided in the document. The document states that "The design of the Control-IQ+ algorithm is unchanged" from its predicate. This implies that the training of the core algorithm was done prior to the predicate device's clearance and is not being re-evaluated for this submission. The 510(k) is primarily about demonstrating safety and effectiveness in the expanded user population, not re-training or re-validating the core algorithm's initial development.

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

• This information is not provided as the algorithm itself is stated to be unchanged from the predicate device. Details about the original algorithm's development, including its training data and how its ground truth was established, would have been part of the predicate device's (K232382) submission.

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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 2 years of age and greater.

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

Control-IQ technology (Control-IQ, the device) is a software-only device intended for the management of type 1 diabetes mellitus. 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 has three different modes: Normal, Sleep, and Exercise. The glucose targets are not customizable in these modes but can change based on the mode selected. During normal mode, Control-IQ Technology aims to control glucose within a target range of 112.5 – 160 mg/dL. 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-IQ technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.

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

The provided text describes the acceptance criteria and the study conducted for the Tandem Diabetes Care Control-IQ Technology (K232382).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria for the Control-IQ technology. However, it states the primary outcome of the pivotal clinical study. The device's performance is reported in relation to this outcome.

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

• Sample Size: 102 subjects were enrolled in the pivotal clinical study.
• Data Provenance: The document does not specify the country of origin. It indicates the study was a prospective, randomized controlled trial.

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

This information is not provided in the document. The study's "ground truth" for glucose values would inherently come from the continuous glucose monitors (CGM) used by the subjects in the trial, but the involvement of independent experts to establish a "ground truth" for the test set is not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

A MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an automated glycemic controller, where the AI (Control-IQ technology) directly controls insulin delivery, rather than assisting human interpretation of data for medical decision making.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the pivotal clinical study directly evaluated the performance of the Control-IQ technology (algorithm only without human-in-the-loop for basal insulin adjustments and correction boluses based on predictions). Subjects were randomized to either Control-IQ or Standard Care, directly comparing the automated system's performance.

7. The Type of Ground Truth Used

The ground truth for the primary outcome (percent time in range 70-180 mg/dL) was based on CGM measured glucose values.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the Control-IQ algorithm. The clinical study described is a pivotal trial for evaluation of the device, not necessarily for its training.

9. 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.

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 6 years of age and greater.

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

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

The Control-IQ technology, is an interoperable automated glycemic controller. This is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated divcemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining qlycemic control.

The provided text is a 510(k) summary for Tandem Diabetes Care's Control-IQ technology. While it states that a clinical study was performed, it does not provide any specific acceptance criteria or detailed results of that study (e.g., specific metrics like mean glucose, time in range, or hypoglycemia rates). It only generically states that it "demonstrates that the device is safe and effective in the population evaluated (ages ≥ 6 and ≤ 13 years old)."

Therefore, I cannot fulfill all parts of your request with the given information. However, I can extract what is provided.

Here's a summary based on the provided text, highlighting the missing information:

Description of Acceptance Criteria and Proving Study

The provided 510(k) summary for the Control-IQ technology indicates that a clinical study was performed to assess the efficacy and safety of the device. However, the document does not explicitly state the specific acceptance criteria used for this study, nor does it provide detailed performance metrics or results from the study. It only makes a general statement about the device being safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions a "randomized controlled trial" but does not specify the sample size of participants in this trial.
• Data Provenance: The document does not specify the country of origin of the data. It implies the study was prospective ("randomized controlled trial").

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Not applicable for this type of device. The "ground truth" for glycemic control in a clinical study is typically established by objective physiological measurements (e.g., CGM readings, lab glucose values) rather than expert review of images or medical records.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Adjudication methods are typically used when there's subjective interpretation involved, such as in image-based diagnostics. For a glycemic control device, the primary "data" are objective glucose measurements.

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

• No. An MRMC study is not relevant for this type of device (automated glycemic controller). These studies are typically used for diagnostic devices that involve human interpretation of medical images or other data. This device is an automated system designed to manage glucose levels directly.

6. Standalone Performance Study

• Yes, implicitly. The clinical study performed on the Control-IQ technology assessed the device's performance (efficacy and safety) as an automated system. While it interacts with an iCGM and an ACE pump, the "Control-IQ technology" itself is the algorithm and software component being evaluated for its standalone ability to manage glucose. The study evaluated its performance, not how it assists a human to perform a task.

7. Type of Ground Truth Used

• The ground truth for evaluating an automated glycemic controller in a clinical study would be based on physiological measurements such as:
  • Continuous Glucose Monitoring (CGM) data
  • Laboratory-confirmed blood glucose values
  • Clinical outcomes data (e.g., episodes of hypoglycemia/hyperglycemia, hospitalizations, DKA events).
  • The document does not explicitly state the specific ground truth metrics used, but these are standard for such studies.

8. Sample Size for the Training Set

• Not provided. The document does not mention the sample size or details of any training set used for developing or training the Control-IQ algorithm. It only refers to a "Clinical study" for validation.

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

• Not provided. Since details about a training set are not mentioned, how its ground truth was established is also not available in this document.

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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).

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