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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 melliting 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 2 years of age and greater.

The t:slim X2 Insulin Pump with Interoperable Technology 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 t:slim X2 insulin pump includes a disposable cartridge with a 300 unit reservoir which is filled with insulin by the user with the use of the syringe and needle. The cartridge needs to be changed every 48-72 hours depending on the type of insulin used.

The pump 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 pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, execute, and confirm commands from these devices.

The t:connect mobile app enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The t:connect mobile app can transmit pump and therapy data from the pump to the cloud as long as the user's smartphone is connected to the internet.

The pump is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices.

The pump is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (K200467) to aid in diabetes management. The latter is being submitted concurrently.

In addition, the Subject Device is compatible with iCGM systems cleared under K223931 21 CFR 862.1355.

The provided text describes the 510(k) summary for the Tandem Diabetes Care t:slim X2 Insulin Pump with Interoperable Technology (K232380). This submission focuses on a change to the age indication for the device, lowering it to individuals 2 years of age and greater.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error rates) for the device's performance in relation to the expanded age indication. Instead, it makes a general statement about safety and effectiveness.

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

The document mentions "clinical testing was performed to support the expanded age indication" and "the clinical testing provided in this 510(k) demonstrate that the t:slim X2 Insulin Pump with Interoperable Technology is the same as the predicate device in safety and effectiveness."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, the nature of "clinical testing" for an expanded age indication typically implies a prospective clinical study involving the new patient population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text does not describe a process of expert review or establishing ground truth in the context of the clinical testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided in the document. The study described is a clinical evaluation of the device itself rather than a comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an insulin pump, which is a physical medical device that delivers insulin. While it has interoperable technology and can communicate with automated insulin dosing software, the "performance data" mentioned pertains to the overall device in a clinical setting with human interaction (patient programming, healthcare provider recommendations). Therefore, a "standalone algorithm only" performance study as typically understood for AI/CAD devices is not directly applicable or explicitly described in this context. The focus is on the device's safety and effectiveness for insulin delivery in the expanded age group.

7. The Type of Ground Truth Used

The "ground truth" for the clinical testing would be the actual physiological responses and outcomes of the pediatric patients using the insulin pump, as assessed by healthcare professionals. This would include parameters like blood glucose levels, incidence of hypoglycemia/hyperglycemia, and adverse events. The document refers to "safety and effectiveness," which points to clinical outcomes.

8. The Sample Size for the Training Set

The document describes a clinical study to support an expanded age indication for an existing device. This implies that the device's core algorithm and functionality were developed and "trained" (in a non-AI sense, meaning designed and validated) prior to this specific submission. The text does not provide information regarding a training set for an AI/algorithm, as this submission is not about the initial development or a new AI component. If the "interoperable technology" involves AI, the training data for that specific AI component is not detailed here.

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

Given that this submission is for an expanded age indication of an existing device, and not a new AI model, the concept of a "training set" and its ground truth establishment, as typically understood for AI/ML, is not applicable or described in this document. The device's fundamental insulin delivery mechanism and safety profile would have been established through prior design, testing, and regulatory submissions. The current clinical testing validates the device's safety and effectiveness for a younger population.

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