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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.

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The t:slim X2 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 melliting 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.

The t:slim X2 Insulin Pump with Interoperable Technology is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The t:slim X2 insulin pump includes a disposable cartridge with a 300 unit reservoir which is filled with insulin by the user with the use of the syringe and needle. The cartridge needs to be changed every 48-72 hours depending on the type of insulin used.

The pump is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations.

The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, execute, and confirm commands from these devices.

The t:connect mobile app enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The t:connect mobile app can transmit pump and therapy data from the pump to the cloud as long as the user's smartphone is connected to the internet.

The pump is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices.

The pump is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (K200467) to aid in diabetes management. The latter is being submitted concurrently.

In addition, the Subject Device is compatible with iCGM systems cleared under K223931 21 CFR 862.1355.

The provided text describes the 510(k) summary for the Tandem Diabetes Care t:slim X2 Insulin Pump with Interoperable Technology (K232380). This submission focuses on a change to the age indication for the device, lowering it to individuals 2 years of age and greater.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error rates) for the device's performance in relation to the expanded age indication. Instead, it makes a general statement about safety and effectiveness.

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

The document mentions "clinical testing was performed to support the expanded age indication" and "the clinical testing provided in this 510(k) demonstrate that the t:slim X2 Insulin Pump with Interoperable Technology is the same as the predicate device in safety and effectiveness."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, the nature of "clinical testing" for an expanded age indication typically implies a prospective clinical study involving the new patient population.

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

This information is not provided in the document. The text does not describe a process of expert review or establishing ground truth in the context of the clinical testing.

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

This information is not provided in the document. The study described is a clinical evaluation of the device itself rather than a comparison of human readers with and without AI assistance.

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

The device is an insulin pump, which is a physical medical device that delivers insulin. While it has interoperable technology and can communicate with automated insulin dosing software, the "performance data" mentioned pertains to the overall device in a clinical setting with human interaction (patient programming, healthcare provider recommendations). Therefore, a "standalone algorithm only" performance study as typically understood for AI/CAD devices is not directly applicable or explicitly described in this context. The focus is on the device's safety and effectiveness for insulin delivery in the expanded age group.

7. The Type of Ground Truth Used

The "ground truth" for the clinical testing would be the actual physiological responses and outcomes of the pediatric patients using the insulin pump, as assessed by healthcare professionals. This would include parameters like blood glucose levels, incidence of hypoglycemia/hyperglycemia, and adverse events. The document refers to "safety and effectiveness," which points to clinical outcomes.

8. The Sample Size for the Training Set

The document describes a clinical study to support an expanded age indication for an existing device. This implies that the device's core algorithm and functionality were developed and "trained" (in a non-AI sense, meaning designed and validated) prior to this specific submission. The text does not provide information regarding a training set for an AI/algorithm, as this submission is not about the initial development or a new AI component. If the "interoperable technology" involves AI, the training data for that specific AI component is not detailed here.

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

Given that this submission is for an expanded age indication of an existing device, and not a new AI model, the concept of a "training set" and its ground truth establishment, as typically understood for AI/ML, is not applicable or described in this document. The device's fundamental insulin delivery mechanism and safety profile would have been established through prior design, testing, and regulatory submissions. The current clinical testing validates the device's safety and effectiveness for a younger population.

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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.

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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 (K203234) 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.

The provided document is a 510(k) summary for the Tandem Mobi insulin pump. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the format requested.

Here's an analysis of the provided text in relation to your questions:

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

The document does not provide a specific table of acceptance criteria with corresponding device performance metrics in the format you requested, such as sensitivity, specificity, or similar quantitative measures for an AI-driven diagnostic. Instead, it describes general non-clinical performance tests and states that the device "met specified requirements" or "performed as intended."

2. Sample size used for the test set and the data provenance

The document explicitly states: "No new clinical testing was performed to support this Traditional 510(k) Notification." Therefore, there is no test set of patient data from a clinical study to report on for the Tandem Mobi insulin pump itself. The evaluation relies on non-clinical performance tests and comparison to a predicate device.

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

Since no new clinical testing was performed, the concept of "ground truth" derived from expert consensus on a test set is not applicable here.

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

Not applicable, as no new clinical testing was performed.

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

Not applicable. The Tandem Mobi insulin pump is an Alternate Controller Enabled (ACE) Infusion Pump intended for insulin delivery, not a diagnostic device requiring human interpretation of medical images or data. Therefore, an MRMC study and the concept of "human readers improve with AI assistance" are not relevant to this device's evaluation.

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

The device itself is a pump for insulin delivery. While it has "interoperable technology" connecting to a mobile app and potentially automated insulin dosing software, the document doesn't describe a standalone algorithm performance in the context of a diagnostic AI system. The "algorithm only" would likely pertain to the internal control logic of the pump or any integrated automated dosing algorithms (which are referenced as separate devices like Control-IQ technology). The evaluation here focuses on the pump as a system, including its communication capabilities.

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

Given the nature of the device (an insulin pump), the "ground truth" for its performance would typically involve:

• Physiological measurements: Accurate insulin delivery, blood glucose control (as observed in predicate/reference device studies, not new studies for this 510k).
• Engineering specifications: Meeting defined tolerances for flow rate, pressure, safety, etc. (evaluated in non-clinical tests).
• System Integrity: Reliability of communication, software function, alarm systems, etc. (evaluated in non-clinical tests).

The summary indicates that Usability/Human Factors, Software Verification and Validation, Electrical Safety/EMC, Insulin Compatibility and Biocompatibility, and Sterilization and Shipping tests were performed. These tests use their own respective "ground truths" in the form of pre-defined requirements, standards (e.g., IEC 60601), or established safety profiles. For instance, in "Insulin Compatibility," the ground truth is that the insulin performs "as intended" in the device, presumably based on its known pharmacological properties and stability.

8. The sample size for the training set

Not applicable, as no new clinical testing or development of a new AI algorithm (in the diagnostic sense) is described. The device is a medical device leveraging established technology for insulin delivery.

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

Not applicable.

Summary Regarding Acceptance Criteria and Study:

The document effectively communicates that the Tandem Mobi insulin pump's acceptance criteria are primarily based on non-clinical performance tests demonstrating compliance with relevant standards and guidelines, and its substantial equivalence to an existing predicate device (K203234, the t:slim X2 Insulin Pump with interoperable technology).

The "study that proves the device meets the acceptance criteria" consists of:

• Usability/Human Factors validation testing: To ensure users can safely and effectively operate the device.
• Software Verification and Validation: To confirm the software meets requirements and performs as intended, adhering to standards like IEC 62304 and FDA guidance. This includes cybersecurity evaluations.
• Electrical Safety/EMC Testing: To ensure compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601).
• Insulin Compatibility and Biocompatibility Testing: To confirm the device functions correctly with approved insulins and that materials are biocompatible.
• Sterilization and Shipping Testing: To ensure the integrity of the device and its sterilization.
• Special Controls Adherence: Demonstrating compliance with special controls established for the predicate and reference devices.

The key takeaway is that for this 510(k) submission, the safety and effectiveness of the Tandem Mobi insulin pump are established through bench testing, engineering validation, and comparison to a legally marketed predicate device, rather than new clinical trials with patient-level data and AI performance metrics.

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The t:slim X2 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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.

The t:connect mobile app can be wirelessly paired to the t:slim X2 Insulin Pump with Interoperable Technology, for the purposes of allowing limited control of bolus insulin therapy. The t:connect mobile app is available on iOS and Android compatible smartphones via the Apple Store® and Google Play Store®. When successfully paired with The Pump, users have the ability to perform the following via the t:connect mobile app:

• View The Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
• Program Correction Boluses, Bolus Override, and Food (Standard) Boluses.
• Terminate (Cancel or stop) all bolus types regardless of origin of bolus request being made on the t:slim X2 Insulin Pump or the t:connect mobile app.
  Outside of programming and terminating boluses, the t:connect mobile app will have no other controlling action on The Pump.

The provided document describes the FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app). It focuses on the addition of the mobile app to allow limited control of bolus insulin therapy.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No specific quantitative acceptance criteria or detailed study results (like sensitivity, specificity, or specific error rates) are explicitly reported in this 510(k) summary for the t:connect mobile app. The submission primarily relies on non-clinical testing (human factors, software verification and validation, cybersecurity) and demonstrates substantial equivalence to a predicate device.

The clearance is for a medical device (insulin pump with a mobile app for control), not an AI/ML algorithm that predicts or diagnoses based on data. Therefore, many of the typical AI/ML study components (like expert ground truth establishment, MRMC studies, standalone algorithm performance, or specific performance metrics like AUC, sensitivity, specificity, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for this device.

The study aims to demonstrate that the mobile app addition is safe and effective and does not raise new questions of safety or effectiveness compared to the predicate device.

Acceptance Criteria and Reported Device Performance

Given the nature of this device (insulin pump with a mobile app for control), the "acceptance criteria" are more about functionality, safety, and human usability rather than diagnostic accuracy metrics.

• Viewing Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
• Programming Correction Boluses, Bolus Override, and Food (Standard) Boluses.
• Terminating (Cancelling or stopping) all bolus types regardless of origin of bolus request.
  Pump functions independently from the mobile app.
  Mobile app does not control or impact automated dosing algorithms (Basal-IQ, Control-IQ).
  Bolus Calculator: Mobile app includes a built-in Bolus Calculator with the same purpose and function as the Pump's. Pump sends info to app for bolus calculation.
  Display of Alerts/Notifications: Mobile app displays Pump Notifications, Alerts, Alarms, and Reminders. Specific alerts for "Pump Connection Lost" and "t:connect Mobile App Incomplete Bolus Alert." Specific notification for "Bolus in Progress on Pump." (Mobile app cannot clear/alter; requires Pump for that.)
  Logging Critical Events: Pump logs bolus requests and terminations from the app. Mobile app logs actions of bolus initiation/termination. | The device (Pump with t:connect mobile app) met specified requirements and performed as intended.
• The t:connect mobile app enables the listed functionalities for viewing data and controlling bolus insulin.
• The mobile app and pump retain independent functionality where appropriate.
• The bolus calculator functions as described.
• Alerts, alarms, and notifications are displayed on the app as intended.
• Critical events, including actions from the mobile app, are logged by the system. |
  | Safety | Human Factors: Demonstrate intended users can effectively use the Subject Device for its intended purpose in expected use environments, ensuring safe use.
  Software Verification & Validation (V&V): Ensure software conforms to patient needs and intended uses, implying absence of critical errors, accurate execution of commands, and data integrity.
  Cybersecurity: Evaluate and ensure the device's resilience against cyber threats to prevent unauthorized access or manipulation.
  Risk Management: Compliance with ISO 14971 implies a robust risk management process. | Human Factors: Results from the human factors study demonstrate users can safely and effectively use the features of the Subject Device.
  Software V&V: Carried out activities (requirements linking, code inspection, static analysis, unit/system testing) to ensure specified conformity.
  Cybersecurity: Evaluations were carried out.
  Risk Management: Compliance with relevant standards (ISO 14971, IEC 62304) for risk management and software lifecycle processes implicitly ensures safety.
  Overall: The device does not raise any new or different questions of safety or effectiveness. |
  | Effectiveness | The device, with the mobile app, should continue to effectively manage diabetes mellitus in persons requiring insulin. The mobile app's role is to facilitate limited control of bolus insulin therapy. | The device functions as an alternate controller enabled infusion pump, providing the intended functionality for insulin delivery and bolus control via the app. |

Study Details

1. Sample sizes used for the test set and data provenance:
   This document focuses on non-clinical testing (human factors, software V&V, cybersecurity) and does not specify a "test set" in the context of a clinical trial or algorithm performance evaluation on a patient dataset.

   • Human Factors Validation Testing: While the document states "Human factors validation testing was conducted," it does not specify the sample size (number of participants) or data provenance (e.g., country of origin, retrospective/prospective).
   • Software Verification and Validation: This testing involves internal software evaluations, code reviews, unit testing, and system-level testing. There isn't typically a "sample size" in the same way as a clinical dataset for these activities. The provenance relates to the software development process itself.
   • No new clinical testing was required. This indicates no patient data was used for a new clinical study to support this specific 510(k) for the mobile app.

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

   • Not Applicable/Not Specified in this context. For human factors, "ground truth" would be related to user performance outcomes and safety, assessed by usability engineers or similar experts rather than medical specialists establishing diagnostic ground truth from images or clinical data. The document does not specify the number or qualifications of experts for these assessments.

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

   • Not Applicable/Not Specified. This type of adjudication is typically for establishing medical "ground truth" in diagnostic studies, which was not performed here.

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:

   • No. This type of study (MRMC for AI assistance) is not applicable to an insulin pump and its control app. This device does not involve "human readers" interpreting medical images or data with or without AI assistance.

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

   • Not Applicable in the traditional AI/ML sense. The software itself undergoes comprehensive standalone verification and validation to ensure its functional correctness and safety, but this is distinct from "standalone performance" of a diagnostic AI algorithm. The device, including the app, is designed for human-in-the-loop use for insulin delivery.

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

   • Not Applicable. For a device like an insulin pump and its control app, "ground truth" isn't established in the same way as for diagnostic AI. Instead, the "ground truth" for safety and effectiveness is established through:
     • Functional Requirements: The expected, correct operation of the software and hardware.
     • Usability Objectives: The desired safe and effective user interaction, verified through human factors testing.
     • Regulatory Standards & Guidance: Adherence to established medical device software, cybersecurity, and risk management standards.

7. The sample size for the training set:

   • Not Applicable. This device is not described as using machine learning that has a "training set" in the context of data-driven model training. Its functionality is based on pre-defined algorithms for insulin delivery control.

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

   • Not Applicable. No training set for an AI/ML algorithm is mentioned.

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