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The FREEDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring 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, palm, thigh and calf.

The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM 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.

This is an in vitro diagnostic device, not an AI/ML device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample size for training set) are not applicable. The information provided focuses on the device's accuracy against established references, which is typical for this type of device.

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state acceptance criteria in a quantitative table format nor reported device performance in a similar table. However, based on the nature of blood glucose monitoring systems and the reference to substantial equivalence to predicate devices, the acceptance criteria would implicitly involve the device demonstrating accuracy and precision comparable to or better than the predicate devices and meeting relevant ISO standards for blood glucose monitoring.

From the information provided, it states that the device measures "the concentration of glucose in whole blood" and is "an aid in monitoring the effectiveness of diabetes management." The device claims "substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®" and others. This implies that the performance (accuracy, precision) of the FREEDOM Blood Glucose Monitoring System must be within acceptable limits relative to these established predicate devices.

Implicit Acceptance Criteria (based on common standards for IVD blood glucose meters) & Reported Device Performance:

Note: The 510(k) summary itself does not contain a detailed performance study report with specific accuracy or precision statistics for the FREEDOM Blood Glucose Monitoring System. The claim of "substantial equivalence" is the primary basis for market clearance, implying that the detailed performance data submitted to the FDA (but not included in this summary) demonstrated comparable performance to the predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:
   The provided summary does not include specific details about the sample size used for performance testing or the provenance of the data (e.g., country of origin, retrospective/prospective). For an in vitro diagnostic device like a blood glucose meter, the test set would typically involve human blood samples across a range of glucose concentrations, tested against a reference method.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable for a blood glucose monitoring system. The "ground truth" for blood glucose measurements is established by a highly accurate and precise laboratory reference method (e.g., an enzymatic hexokinase method on a laboratory analyzer), not by human expert opinion.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable. Adjudication methods involving multiple human readers are used for subjective interpretations (e.g., image analysis, clinical diagnoses). For quantitative measurements like blood glucose, the reference method provides a definitive quantitative value, not a subjective interpretation requiring adjudication.

4. 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:
   This is not applicable. An MRMC study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. This device is a standalone in vitro diagnostic system for measuring a biochemical analyte. It does not involve human readers or AI assistance in interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, this is implicitly a standalone performance study. The FREEDOM Blood Glucose Monitoring System is an "algorithm only" type of device in the sense that it performs a chemical and electrical measurement and provides a numerical output without human interpretation being part of its diagnostic function. Its performance is evaluated on its ability to accurately and precisely provide glucose concentrations compared to a reference standard. The product description emphasizes the electrochemical signal and its measurement by the meter, displayed as a blood glucose result.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth would be established by a highly accurate and precise laboratory-based reference method for glucose measurement, such as a hexokinase enzymatic method or isotope dilution-mass spectrometry (IDMS), performed on a clinical laboratory analyzer.

7. The sample size for the training set:
   This is not applicable in the context of traditional in vitro diagnostic devices like blood glucose meters. There is no "training set" in the machine learning sense. The device's electrochemical principles and algorithms are fixed during design and manufacturing. Performance is validated through testing on clinical samples, not by iterative training.

8. How the ground truth for the training set was established:
   As there is no training set in the AI/ML sense, this question is not applicable. The device's operating principles and internal calibration are established during its engineering design, and its accuracy is validated against a definitive laboratory reference standard.

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