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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.

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