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The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario meter is connected to a SMD through a standard 3.5mm audio plug in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.

The provided text describes the Dario Blood Glucose Monitoring System and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device "meets all of its associated specifications" and that performance and safety testing "confirmed the proposed device to be substantially equivalent to the predicate device." However, specific numerical acceptance criteria (e.g., accuracy percentages) are not explicitly stated in this summary. The categories of performance assessed include:

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

• Test Set Sample Size: The document mentions a "User Performance study" for the expanded indications. However, the specific sample size used for this study is not provided in the given text.
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

Given that this is a Blood Glucose Monitoring System, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" as typically understood in imaging diagnostics (human readers reviewing cases) is not applicable. The "User Performance study" mentioned would likely involve human users operating the device, but not in the context of interpreting results in a comparative effectiveness study with AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

The Dario Blood Glucose Monitoring System comprises "the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component." The description states, "The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function." This implies that the core glucose measurement performance is inherent in the meter and test strips, which would have been tested in a standalone manner (in vitro performance). The app primarily acts as a display. The "User Performance study" would involve human users operating the system, incorporating a "human-in-the-loop" aspect for usability and performance in real-world scenarios.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth for accuracy and precision studies is typically established using:

• Reference laboratory methods: Such as a YSI glucose analyzer, which is considered highly accurate for blood glucose measurements.
• Clinical laboratory results: From comparative devices.

While not explicitly stated as "ground truth" in the provided text, the "In Vitro" performance and "Accuracy" assessments would rely on comparison to these established reference methods.

8. The Sample Size for the Training Set

This information is not provided in the given text, as the device is not described as having an AI algorithm that requires a training set in the conventional sense (e.g., for image recognition). The "Software" section refers to documentation for a moderate level of concern device, which typically relates to software validation and verification, not machine learning model training.

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

As there is no mention of an AI algorithm or a training set in the conventional sense, this information is not applicable and therefore not provided in the document.

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The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips. Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Dario is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.

The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store.

Test Principle:

The Dario Blood Glucose Monitoring System is an in vitro diagnostic device intended for the measurement of glucose in fresh whole capillary blood. The principle of the test relies upon a reaction between a specific type of sugar (glucose) in the blood sample and the glucose oxidase in the test strip. This reaction generates a small electrical current, which is measured by the meter. The meter calculates the blood glucose level based on an internal algorithm. The Dario application displays the test result via the smart mobile device display.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Dario Blood Glucose Monitoring System, structured according to your request:

Acceptance Criteria and Device Performance

A key study for glucose monitoring systems is System Accuracy. The ISO 15197:2003 standard defines acceptance criteria for system accuracy. The device performance is reported against this standard.

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