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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 t:connect mobile app can be wirelessly paired to the t:slim X2 Insulin Pump with Interoperable Technology, for the purposes of allowing limited control of bolus insulin therapy. The t:connect mobile app is available on iOS and Android compatible smartphones via the Apple Store® and Google Play Store®. When successfully paired with The Pump, users have the ability to perform the following via the t:connect mobile app:

• View The Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
• Program Correction Boluses, Bolus Override, and Food (Standard) Boluses.
• Terminate (Cancel or stop) all bolus types regardless of origin of bolus request being made on the t:slim X2 Insulin Pump or the t:connect mobile app.
  Outside of programming and terminating boluses, the t:connect mobile app will have no other controlling action on The Pump.

The provided document describes the FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app). It focuses on the addition of the mobile app to allow limited control of bolus insulin therapy.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No specific quantitative acceptance criteria or detailed study results (like sensitivity, specificity, or specific error rates) are explicitly reported in this 510(k) summary for the t:connect mobile app. The submission primarily relies on non-clinical testing (human factors, software verification and validation, cybersecurity) and demonstrates substantial equivalence to a predicate device.

The clearance is for a medical device (insulin pump with a mobile app for control), not an AI/ML algorithm that predicts or diagnoses based on data. Therefore, many of the typical AI/ML study components (like expert ground truth establishment, MRMC studies, standalone algorithm performance, or specific performance metrics like AUC, sensitivity, specificity, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for this device.

The study aims to demonstrate that the mobile app addition is safe and effective and does not raise new questions of safety or effectiveness compared to the predicate device.

Acceptance Criteria and Reported Device Performance

Given the nature of this device (insulin pump with a mobile app for control), the "acceptance criteria" are more about functionality, safety, and human usability rather than diagnostic accuracy metrics.

• Viewing Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
• Programming Correction Boluses, Bolus Override, and Food (Standard) Boluses.
• Terminating (Cancelling or stopping) all bolus types regardless of origin of bolus request.
  Pump functions independently from the mobile app.
  Mobile app does not control or impact automated dosing algorithms (Basal-IQ, Control-IQ).
  Bolus Calculator: Mobile app includes a built-in Bolus Calculator with the same purpose and function as the Pump's. Pump sends info to app for bolus calculation.
  Display of Alerts/Notifications: Mobile app displays Pump Notifications, Alerts, Alarms, and Reminders. Specific alerts for "Pump Connection Lost" and "t:connect Mobile App Incomplete Bolus Alert." Specific notification for "Bolus in Progress on Pump." (Mobile app cannot clear/alter; requires Pump for that.)
  Logging Critical Events: Pump logs bolus requests and terminations from the app. Mobile app logs actions of bolus initiation/termination. | The device (Pump with t:connect mobile app) met specified requirements and performed as intended.
• The t:connect mobile app enables the listed functionalities for viewing data and controlling bolus insulin.
• The mobile app and pump retain independent functionality where appropriate.
• The bolus calculator functions as described.
• Alerts, alarms, and notifications are displayed on the app as intended.
• Critical events, including actions from the mobile app, are logged by the system. |
  | Safety | Human Factors: Demonstrate intended users can effectively use the Subject Device for its intended purpose in expected use environments, ensuring safe use.
  Software Verification & Validation (V&V): Ensure software conforms to patient needs and intended uses, implying absence of critical errors, accurate execution of commands, and data integrity.
  Cybersecurity: Evaluate and ensure the device's resilience against cyber threats to prevent unauthorized access or manipulation.
  Risk Management: Compliance with ISO 14971 implies a robust risk management process. | Human Factors: Results from the human factors study demonstrate users can safely and effectively use the features of the Subject Device.
  Software V&V: Carried out activities (requirements linking, code inspection, static analysis, unit/system testing) to ensure specified conformity.
  Cybersecurity: Evaluations were carried out.
  Risk Management: Compliance with relevant standards (ISO 14971, IEC 62304) for risk management and software lifecycle processes implicitly ensures safety.
  Overall: The device does not raise any new or different questions of safety or effectiveness. |
  | Effectiveness | The device, with the mobile app, should continue to effectively manage diabetes mellitus in persons requiring insulin. The mobile app's role is to facilitate limited control of bolus insulin therapy. | The device functions as an alternate controller enabled infusion pump, providing the intended functionality for insulin delivery and bolus control via the app. |

Study Details

1. Sample sizes used for the test set and data provenance:
   This document focuses on non-clinical testing (human factors, software V&V, cybersecurity) and does not specify a "test set" in the context of a clinical trial or algorithm performance evaluation on a patient dataset.

   • Human Factors Validation Testing: While the document states "Human factors validation testing was conducted," it does not specify the sample size (number of participants) or data provenance (e.g., country of origin, retrospective/prospective).
   • Software Verification and Validation: This testing involves internal software evaluations, code reviews, unit testing, and system-level testing. There isn't typically a "sample size" in the same way as a clinical dataset for these activities. The provenance relates to the software development process itself.
   • No new clinical testing was required. This indicates no patient data was used for a new clinical study to support this specific 510(k) for the mobile app.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable/Not Specified in this context. For human factors, "ground truth" would be related to user performance outcomes and safety, assessed by usability engineers or similar experts rather than medical specialists establishing diagnostic ground truth from images or clinical data. The document does not specify the number or qualifications of experts for these assessments.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable/Not Specified. This type of adjudication is typically for establishing medical "ground truth" in diagnostic studies, which was not performed here.

4. 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:

   • No. This type of study (MRMC for AI assistance) is not applicable to an insulin pump and its control app. This device does not involve "human readers" interpreting medical images or data with or without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable in the traditional AI/ML sense. The software itself undergoes comprehensive standalone verification and validation to ensure its functional correctness and safety, but this is distinct from "standalone performance" of a diagnostic AI algorithm. The device, including the app, is designed for human-in-the-loop use for insulin delivery.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. For a device like an insulin pump and its control app, "ground truth" isn't established in the same way as for diagnostic AI. Instead, the "ground truth" for safety and effectiveness is established through:
     • Functional Requirements: The expected, correct operation of the software and hardware.
     • Usability Objectives: The desired safe and effective user interaction, verified through human factors testing.
     • Regulatory Standards & Guidance: Adherence to established medical device software, cybersecurity, and risk management standards.

7. The sample size for the training set:

   • Not Applicable. This device is not described as using machine learning that has a "training set" in the context of data-driven model training. Its functionality is based on pre-defined algorithms for insulin delivery control.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set for an AI/ML algorithm is mentioned.

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