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VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.

The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.

VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability.

Here's a breakdown of the acceptance criteria and study information for the VivaChek™ Blood Glucose and ß-Ketone Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria values for most studies, but rather states that the studies "Pass" or "were acceptable." For the performance characteristics, it focuses on demonstrating equivalence to the predicate device. For the clinical study, the acceptance criteria were based on participants' ability to obtain readings and satisfaction with ease of operation and overall performance.

For the B-Ketone performance studies, generally, the acceptance criteria for a blood ketone monitoring system would align with ISO 15197 or similar guidelines, requiring a certain percentage of results to fall within defined accuracy ranges when compared to a reference method (e.g., laboratory analyzer). While not explicitly stated with numerical targets, the "Pass" conclusion for studies like Linearity, Precision, and Interfering Agents implies adherence to such generally accepted analytical performance standards.

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

The document does not explicitly state the sample sizes for the individual non-clinical (laboratory) studies. For the User Evaluation (clinical study), it refers to "participated lay persons" without specifying the exact number.

The provenance of the data is not mentioned in terms of country of origin. The studies are described as "non-clinical (laboratory) studies" and a "clinical (user evaluation) study," indicating they are likely prospective experiments conducted specifically for this submission.

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

This information is not provided in the document. For analytical devices like this, ground truth for accuracy studies (e.g., Linearity, Precision) would typically be established by a reference laboratory method using highly accurate and calibrated instruments, not necessarily by experts in the sense of human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of a quantitative measurement device, the comparison would typically be against a reference method, rather than requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation of images or other subjective data, which is not the case for a blood ketone and glucose monitoring system.

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

Yes, the analytical and performance studies listed (e.g., Linearity, Precision, Hematocrit Effect, Interference) represent standalone (algorithm only) performance of the device without human-in-the-loop interpretation beyond operating the device. The device provides a quantitative numerical output directly. The "User Evaluation" did involve humans, but primarily to assess their ability to use the device and obtain a reading, not to interpret the reading itself.

7. The Type of Ground Truth Used

For the analytical performance studies (e.g., Linearity, Precision, Hematocrit, Interference), the ground truth would typically be established by a reference laboratory method or highly accurate comparative instrument. The document refers to "corresponding study protocols," which would detail these reference methods, but the specific methods are not described in this summary.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is not described as using machine learning or AI that would require a distinct training set in the conventional sense. Its performance is based on established electrochemical principles.

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

As no training set is mentioned or implied for an AI/ML context, this information is not applicable.

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