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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 Subject Device 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 device includes a disposable cartridge which 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 Subject Device can send and receive data to and from other interoperable devices and is designed to act on commands from other authorized digital pump controller devices to adjust insulin dosing. The Subject Device is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices. The Subject Device is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (DEN190034) to aid in diabetes management. In addition, the Subject Device is compatible with iCGM systems cleared under 21 CFR 862.1355 and marketed separately from the ACE Pump and Interoperable Automated Glycemic Controllers.

The Tandem Diabetes Care t:slim X2 Insulin Pump with Interoperable Technology underwent non-clinical testing to confirm that its User Settable Max Basal Limit software update feature met specified requirements and performed as intended.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "human factors validation testing" but does not specify the sample size of participants in this study. The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. It is implied to be prospective and conducted by Tandem Diabetes Care Inc., as it's part of their submission for their device.

3. Number of Experts and Qualifications:

The document does not provide details on the number of experts used to establish ground truth or their specific qualifications for the human factors study. It refers to "intended users" as participants. For software verification and validation, it implies internal experts from Tandem Diabetes Care were involved in activities like code inspection and walkthroughs, but their specific number and qualifications are not mentioned.

4. Adjudication Method:

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The device is an insulin pump, and the evaluation focused on the safety and effectiveness of a new software feature, not on the interpretation of medical images or data by multiple readers.

6. Standalone Performance:

Yes, a standalone performance of the algorithm (or the software feature in this case) was done through "software verification and validation testing." This testing ensured the software conformed to patient needs and intended uses independently. The human factors study also evaluated the device's performance when used by intended users, but the software's foundational performance was assessed in isolation.

7. Type of Ground Truth Used:

For the human factors study, the ground truth was based on the ability of "intended users" to "effectively use the Subject Device for its' intended purpose in expected use environments" as evaluated against established usability standards (ANSI AAMI HE 75:2009, ANSI/AAMI/IEC 62366-1:2015, and FDA guidance).

For software verification and validation, the ground truth was conformity to defined "detailed software requirements," "patient needs," and "intended uses."

8. Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its sample size. Software development and verification and validation processes were used, which would involve iterative development and testing, but a distinct training set in the context of machine learning is not applicable here as the description is of a feature update to an existing software, not a new AI algorithm that learns from data.

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

Not applicable, as a distinct training set for a machine learning algorithm is not described. The ground truth for the overall software development and testing was established through detailed software requirements, patient needs, intended uses, and adherence to established software development and risk management standards (ISO 14971-2012, ANSI AAMI IEC 62304:2006/A1:2016, and FDA guidance).

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