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The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).

Here's an analysis of the provided text regarding the FreeStyle 600 Blood Glucose Monitoring System, detailing the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the FreeStyle 600 Blood Glucose Monitoring System outlines its performance studies and a general conclusion of acceptability and comparability to a comparative method. However, specific quantitative acceptance criteria (e.g., accuracy percentages, precision metrics) and detailed reported performance metrics are not explicitly stated in the summary. The summary focuses more on the type of studies conducted and the conclusion of substantial equivalence rather than granular performance data against predefined thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria were not found in the provided text, the table below reflects what was implied and the general conclusion provided.

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

• Sample Size for Test Set: Not explicitly stated. The summary mentions "Performance Studies" conducted in "the laboratory and in clinical settings."
• Data Provenance: The studies were conducted in "the laboratory and in clinical settings by healthcare professionals." The country of origin is not specified, but the submission is to the U.S. FDA, implying the studies were likely conducted in the U.S. or followed U.S. regulatory guidelines. The summary does not specify whether the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The studies were conducted "by healthcare professionals," implying multiple individuals were involved in the clinical settings, but the exact number or their specific roles in establishing ground truth (e.g., as a reference method operator) are not detailed.
• Qualifications of Experts: Not explicitly stated. They are referred to as "healthcare professionals."

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The summary mentions results being "substantially equivalent to a comparative method," but the process by which "ground truth" was established or adjudicated is not described.

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

• MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, not an imaging or diagnostic AI system that typically involves multiple human readers interpreting results. The study design described is focused on the device's accuracy against a recognized reference method.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: The study inherently reflects standalone performance of the device system. The FreeStyle 600 Blood Glucose Monitoring System operates by taking a blood sample and displaying a glucose reading. The "performance studies" would evaluate the accuracy of this system (meter + strips) against a reference method. There is no separate "human-in-the-loop" component in the direct operation of this type of device that would differentiate between an algorithm-only performance and an assisted performance.

7. Type of Ground Truth Used

• Ground Truth Type: A "comparative method" was used. For blood glucose monitoring systems, this typically refers to a highly accurate laboratory reference method for measuring blood glucose, such as a YSI glucose analyzer. The summary states that the device's performance was "substantially equivalent to a comparative method."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not mentioned. The provided summary is for a traditional medical device (blood glucose meter) which does not typically involve machine learning or AI models with distinct "training sets" in the conventional sense. The device's calibration and algorithm are established during its development and manufacturing, not through a separate "training set" of patient data as seen in AI/ML products.

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

• Ground Truth for Training Set: Not applicable. As explained above, for this type of device, there isn't a "training set" with established ground truth in the same way as an AI/ML model. The device's accuracy is validated against reference methods during its development and performance studies.

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