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The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

Here's a breakdown of the acceptance criteria and the study information for the OneTouch® UltraLink™ Blood Glucose Monitoring System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated for specific tests. However, the User Performance study mentions "two U.S. clinical sites," implying a test set collected from human subjects.
   • Data Provenance:
     • Country of Origin: U.S. (for User Performance studies).
     • Retrospective or Prospective: Not explicitly stated, though a "user performance" study generally implies prospective data collection, especially in "clinical sites."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • The document refers to a "reference method" for accuracy. For blood glucose monitoring systems, the ground truth is typically established using a high-precision laboratory analyzer, not "experts" in the human sense. The document does not specify the number or qualifications of individuals operating this reference method.

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

   • Not applicable/Not described. Blood glucose monitoring systems typically compare device readings directly against a highly accurate laboratory reference method, which serves as the "ground truth." There is no mention of physician or expert adjudication for this type of device performance evaluation.

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 is not applicable to a blood glucose monitoring system. This type of study refers to diagnostic imaging or interpretation tasks, where human readers (e.g., radiologists) interpret cases with or without AI assistance. The OneTouch® UltraLink™ is a direct measurement device; its performance is evaluated against a reference method and user ability to operate it, not against human interpretation of complex data.

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

   • Yes, the performance characteristics like Accuracy, Precision, and Linearity are assessed for the "system" (meter and test strips) as a standalone device against a reference method. The "User Performance" study specifically evaluates human interaction with the device, so it includes human-in-the-loop, but the other tests are essentially standalone performance of the measurement technology.

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

   • Reference method: For accuracy, the ground truth was established by a "reference method" (presumably a laboratory analyzer, typically traceable to an international standard like NIST, for precise glucose measurement).
   • No expert consensus, pathology, or outcomes data ground truth was used for the technical performance characteristics.

7. The sample size for the training set

   • Not applicable/Not mentioned. The OneTouch® UltraLink™ Blood Glucose Monitoring System is not an AI/machine learning device that requires a "training set" in the conventional sense. Its underlying technology (enzymatic electrochemical measurement) is well-established, and the system is calibrated during manufacturing.

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

   • Not applicable. As noted above, there is no "training set" for this type of device.

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