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The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.

The G4™ Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.

The G4™ Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.

The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood, which is used with the G4TM Test Strips.

The test principle is:

This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than providing a performance study report with acceptance criteria and results.

Here's what can be inferred from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document. For glucose meters, acceptance criteria typically involve accuracy standards (e.g., ISO 15197 or CLSI guidelines) such as percentage of results within a certain margin of a reference method (e.g., ±15% or ±0.83 mmol/L for glucose < 5.55 mmol/L and ±15% for glucose ≥ 5.55 mmol/L).
• Reported Device Performance: Not detailed in the provided text. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but no specific performance data (e.g., bias, precision, linearity) is included.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no specific test set or ground truth establishment by experts is described for performance evaluation. For glucose meters, ground truth is typically established by laboratory reference methods, not expert consensus.

4. Adjudication method for the test set:

• Not applicable as no specific test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a blood glucose test system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

• The G4™ Meter is a standalone device for measuring glucose. Its "performance" would be its accuracy and precision against a reference method, not an algorithm's performance in a human-in-the-loop context. The document does not provide details of such a standalone performance study.

7. The type of ground truth used:

• Not explicitly stated, but for blood glucose meters, the ground truth is typically established by a laboratory reference method (e.g., a YSI analyzer or similar a high-precision glucose analysis instrument). The document implies that the device's performance is compared to such a standard through the substantial equivalence claim, but no details are given.

8. The sample size for the training set:

• Not applicable. This medical device (blood glucose meter) is an in vitro diagnostic that measures a physiological parameter based on an electrochemical reaction. It is not an AI/ML-based device that requires a "training set" in the conventional sense. Its development would involve calibration and validation, but not machine learning training.

9. How the ground truth for the training set was established:

• Not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Summary of what the document does provide:

• Device Name: G4™ Meter, G4™ Test Strips, G4™ Control Solutions
• Intended Use: Quantitative measurement of glucose level in capillary whole blood for monitoring diabetes management in home and clinical settings.
• Principle of Test: Electrochemical signal generated by glucose dehydrogenase reacting to electrodes.
• Predicate Device: LifeScan, Inc. OneTouch® Ultra® (and others listed in the conclusion).
• Conclusion: Substantially equivalent to the predicate devices.

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