Search Results

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.

Ask a specific question about this device