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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, 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 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 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. Use of CGM is optional.

This document is a 510(k) summary for the Tandem Mobi insulin pump with interoperable technology, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device (K233044).

Based on the provided text, the acceptance criteria and study proving the device meets them pertain to a diabetes management system (insulin pump), not an AI/ML-driven diagnostic or image-analysis device. Therefore, many of the requested points regarding AI/ML study design (e.g., ground truth establishment for a test set, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The document discusses "Clinical Testing" but states that the same testing provided in a previous 510(k) (K232380) was used. This implies that the current submission (K240309) is not presenting a new, dedicated clinical study for its substantial equivalence claim, but rather leveraging prior clinical data from a related submission.

However, I can extract the relevant information from the provided text based on the nature of this device type and the 510(k) submission process.

Here's an analysis based on the document:

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

The document doesn't present a table of specific acceptance criteria in the traditional sense of numerical thresholds for algorithm performance (like sensitivity/specificity for AI). Instead, it relies on demonstrating substantial equivalence to a predicate device (K233044). The "performance" is implicitly deemed acceptable if it performs the same function and does not raise new questions of safety or effectiveness compared to the predicate.

The key changes and comparisons are:

The overall "performance" is that the Subject Device "serves the same function as the Predicate Device" and "performs insulin therapy functions that are the same as that of the Predicate Device." The key performance difference identified is the expanded age indication from 6 years of age and greater to 2 years of age and greater.

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

• Sample Size: Not specified in terms of a "test set" for performance evaluation of an algorithm. The filing mentions "Clinical Testing was provided to support this 510(k) Notification. The clinical testing provided was the same testing provided in 510(k) K232380." The details of sample size for that K232380 study are not in this document.
• Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective). This information would be found in the K232380 submission.

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

Not applicable to this type of device and submission. Ground truth for an insulin pump's functionality is typically established through engineering bench testing, simulated use, and clinical trials (for safety and efficacy in delivering insulin and managing blood glucose), rather than expert radiological review.

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

Not applicable.

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. This is not an AI-assisted diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The device is an insulin pump that works with compatible interoperable technology, including automated insulin dosing software, but details on the performance validation of that software's algorithm are outside the scope of this specific 510(k) summary for the pump itself.

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

For an insulin pump, "ground truth" would relate to its ability to accurately and safely deliver insulin, receive and execute commands, and remain connected. This would be established through:

• Engineering specifications and bench testing (e.g., infusion accuracy, flow rates, alarm functionality).
• Software verification and validation (for reliable communication and command execution).
• Clinical data (likely outcomes data relating to glycemic control, safety, and adverse events if a study was performed in support of K232380).
• Usability/Human Factors testing (ensuring safe and effective interaction for the user).

The document states: "Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended." This testing included:

• Usability/Human Factors (comparative Use Related Risk Analysis only, no new testing)
• Software Verification and Validation (no new testing)
• Electrical Safety/EMC (no new testing)
• Insulin Compatibility and Biocompatibility (no new testing)
• Sterilization and Shipping (no new testing)
• Special Controls (adherence confirmed)
• Clinical Testing (same as K232380)

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that uses training sets in this context.

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

Not applicable.

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 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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