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The Confidence Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The Confidence Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Confidence Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The Confidence Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes or for neonatal use. The Confidence Blood Glucose Test Strips are for use with the Confidence Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

The Confidence™ BGMS consists of test strips stored in a vial with desiccant lining, a hand held blood qlucose meter and a control solution. To perform blood glucose test a test strip is removed from the vial and inserted into Confidence™ meter. On inserting the strip meter gets activated and displays a code, user must select a code corresponding to their strip vial using meter's interface, after selecting correct code, meter will be ready to apply sample by showing a droplet on the LCD display. On applying blood on the end of the test strip a countdown starts and meter LCD displays the plasma equivalent value in the blood sample within 10 seconds in mg/dL unit. The user can validate the operation of the system by using provided control solution. The system uses an electrochemical method based on the GDH-FAD enzyme and a known algorithm, where generated current is directly proportional to glucose concentration.

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The document describes the Confidence Blood Glucose Monitoring System and its performance studies for FDA clearance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for glucose monitoring systems are typically defined by regulatory bodies like the FDA, often referring to standards such as ISO 15197. While the specific standard is not explicitly stated in the provided text as the "acceptance criteria" for the tables below, the data presented aligns with common metrics used in these standards: percentage of results falling within certain accuracy ranges compared to a reference method (YSI 2300).

System Accuracy Results (Trained Person)

User Performance Results (Lay Users)

2. Sample Size and Data Provenance for Test Set

• Sample Size (Trained Person Study): 265 subjects
• Sample Size (Lay User Study): 181 users (results reported for N=187)
• Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US and are prospective in nature. The term "subjects" and "users" implies prospective data collection for these specific studies.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in this context. The ground truth for glucose measurements is established by a reference laboratory instrument, not by human experts.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The ground truth is established by a quantitative reference instrument, eliminating the need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging or subjective interpretations rather than quantitative measurement devices like a blood glucose meter. The studies focused on comparing device performance against a reference standard and user performance.

6. Standalone Performance Study

• Yes, a standalone (algorithm only) performance study was done. The "System Accuracy Results" table (Page 6) and the corresponding linear regression data (Page 7) directly report the performance of the Confidence™ BGMS itself when operated by trained personnel, comparing its readings to the YSI reference standard. The "User Performance Results" also show standalone performance, but in the hands of lay users.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was quantitative reference measurements obtained from an FDA cleared reference method (YSI 2300). The YSI 2300 is a laboratory-grade glucose analyzer often used as the gold standard for glucose measurement in clinical studies.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not specify the sample size used for the training set. The descriptions focus on the validation/test set studies for substantial equivalence. For medical devices, particularly those involving electrochemical sensors, "training" might refer to the development and calibration process rather than a machine learning model's training set in the typical sense. Since it's a device with an algorithm for glucose calculation (based on current measurement), the development process would involve extensive characterization and calibration using various glucose concentrations and interfering substances, but a distinct "training set" in the context of predictive algorithms is not detailed.

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

• Ground Truth for Training Set: The document does not specify how the ground truth for any potential "training set" was established. Assuming "training set" refers to the data used during the development and calibration of the device's measurement algorithm, the ground truth would typically be established using a highly accurate laboratory reference method (like the YSI 2300) with precisely prepared glucose solutions and spiked blood samples across the relevant concentration range, including potentially interfering substances. However, this is inferred based on standard practices for such devices and not explicitly stated in the provided text.

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