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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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