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

The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.

The OneTouch® Vita™ Blood Glucose Monitoring System is a modification of existing predicate devices (OneTouch® Select™ and OneTouch® Ultra®2 meters and OneTouch® Ultra® test strip). The acceptance criteria and performance are based on the ISO 15197:2003(E) standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions that the device was tested in accordance with ISO 15197:2003(E). It does not provide a detailed table of specific acceptance criteria values (e.g., specific percentage agreement within a certain range) or the exact reported performance metrics from the study. Therefore, the table below will list the categories of performance characteristics evaluated based on the ISO standard and the general statement of performance presented in the summary.

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

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "analytical performance testing included system accuracy, repeatability and intermediate precision testing" and "A user performance evaluation assessed usability of the device (human factors) in the hands of intended users."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. For blood glucose monitoring systems, the "ground truth" for system accuracy is typically established by comparative measurements against a laboratory reference method, which is itself calibrated and controlled rather than relying on expert consensus in the same way an imaging device might.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is not applicable here as the ground truth for blood glucose measurements is established through a laboratory reference method, not through consensus read by experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation of images or data is involved. For a blood glucose monitoring system, the performance is measured by the device's accuracy in autonomously measuring glucose levels.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary performance evaluation for the OneTouch® Vita™ Blood Glucose Monitoring System is inherently a "standalone" evaluation. The device (meter and test strip) itself measures glucose concentration independently of human interpretation of the reading. The "user performance evaluation" described is to assess usability and comprehension by human users, not to assess human interpretation of the device's output.

7. The Type of Ground Truth Used

The ground truth for system accuracy is established through comparison to a laboratory reference method. The document states that "A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems." This implies that the device's measurements were compared against highly accurate laboratory glucose measurements.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For medical devices like blood glucose monitors, the development process involves extensive testing and refinement rather than a distinct "training set" in the machine learning sense. The performance characteristics described are from verification and validation testing, which would involve a test set.

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

As there is no explicit mention of a "training set" in the context of this device's regulatory submission, the establishment of ground truth for a training set is not described. The ground truth for the performance evaluation (test set) is established via a laboratory reference method.

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