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VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.

The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.

The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The meter is calibrated to display plasma-like concentration results.

All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.

The VivaChek™ Ino Blood Glucose Monitoring System underwent various tests to demonstrate its accuracy and establish substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text references compliance with EN ISO 15197:2013, which specifies accuracy requirements for blood glucose monitoring systems. While the exact performance metrics from the VivaChek Ino study are not explicitly listed in a direct comparison table within this document, the overall conclusion states that the device "meets the accuracy requirements per EN ISO 15197."

For blood glucose monitoring systems, EN ISO 15197:2013 typically sets the following accuracy criteria against a laboratory reference method (e.g., YSI):

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

• Sample Size:
  • The document states that "Clinical studies were conducted with lay persons and trained laboratory technicians." However, it does not specify the exact number of participants or the number of blood samples collected for the clinical study.
• Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be a submission to the FDA (USA), but the location of the clinical study is not provided. The study was prospective, as it involved direct testing of the device on participants.

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

• Number of Experts: Not applicable in this context. The ground truth for blood glucose monitoring systems is established using a high-accuracy laboratory reference method, not by expert consensus on clinical images or symptoms.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable. The clinical study compares the device's readings directly against a laboratory reference method. There is no subjective interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done in the traditional sense for diagnostic image interpretation.
• Instead, a clinical study was performed comparing the VivaChek™ Ino Blood Glucose Monitoring System's readings (taken by both lay persons and trained laboratory technicians) against a laboratory reference method (YSI Model 2300 STAT PLUS). This is a direct performance evaluation rather than an MRMC study assessing human reader improvement with AI assistance.

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

• Yes, a standalone performance evaluation was done as part of the accuracy assessment. While lay persons and trained technicians performed the tests, the system itself (meter and strips) produces the glucose reading. The study evaluates the accuracy of these readings compared to the reference method, essentially demonstrating the algorithm's performance in generating the glucose value from the blood sample. The role of the human is to properly acquire the sample and operate the device according to instructions, not to interpret an output that the device is assisting them with.

7. The Type of Ground Truth Used

• The ground truth used was laboratory reference measurement from the YSI Model 2300 STAT PLUS (K913806). This is considered a highly accurate and precise method for determining blood glucose concentration.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size for the training set. Blood glucose monitoring systems typically use extensive internal testing, calibration, and potentially clinical data for development and internal validation, which would constitute their "training" analogous to AI. This specific submission focuses on the validation study.

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

• The document does not provide information on how the ground truth for any training set was established. For such devices, manufacturing processes, quality control, and instrument calibration against established standards (often traceable to primary reference materials) are crucial during development, serving a similar function to ground truth establishment for a training set.

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