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ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired.

The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists of the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

Here's a breakdown of the acceptance criteria and study information for the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement "Same accuracy for both systems" and the reference to "Attachment 13.1 System Accuracy Study," which is stated to prove the system meets the performance requirements. While the specific numerical acceptance criteria (e.g., ISO standards for blood glucose meters) are not explicitly detailed in the provided text, the comparison to the predicate device K102316 suggests that the performance requirements are aligned with previously cleared devices.

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

The provided text does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the accuracy, precision, and linearity studies. It only mentions that these studies were conducted and their results are comparable to the predicate device. For the "Lay user evaluation," it mentions an "evaluation report from Arkansas," implying some data was collected within the USA. However, specific numbers for participants or the nature of the data (retrospective/prospective) are not given.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for any of the studies. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory method.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. For blood glucose measurements, ground truth is usually determined by a highly accurate laboratory method, removing the need for expert adjudication in comparing device readings to the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable to this device. This type of study is relevant for imaging devices or diagnostics where human interpretation is involved. The ADVOCATE® Redi-Code+ BMB-EA001S is a blood glucose monitoring system that provides a quantitative measurement, not requiring human interpretation of results in the way an MRMC study would assess. 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

Yes, the primary performance studies (Accuracy, Precision, Linearity, Interference, Altitude, EMC testing) are inherently standalone studies. The device itself performs the measurement and provides a quantitative result. The "Lay user evaluation" focuses on usability and understanding of the speaking function, but the core accuracy is assessed in a standalone manner by comparing device output to reference measurements. The "Blood glucose detection and data analysis algorithm is identical" to the predicate, implying standalone performance.

7. The Type of Ground Truth Used

The ground truth used for performance validation (accuracy, precision, linearity) for blood glucose meters is typically established by laboratory reference methods/instruments. The text refers to "System Accuracy Study" and "Method Comparison Report," which strongly indicates that the device's readings were compared against a gold standard laboratory method for glucose measurement. The nature of the device (quantitative blood glucose meter) makes expert consensus or pathology less relevant for "ground truth" of the measurement itself, though clinical outcomes are relevant for the overall impact of monitoring.

8. The Sample Size for the Training Set

The document does not provide any explicit information about the sample size of a training set. As this device is based on an amperometric method and uses a glucose oxidase enzyme, the "algorithm" for blood glucose concentration calculation, noted as being "Same" as the predicate, is likely a well-established scientific principle rather than a machine learning model requiring a distinct training set in the modern sense. If any form of "training" or calibration data was used for the algorithm, it is not separately detailed.

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

Since an explicit "training set" and its ground truth establishment are not discussed (as per point 8), this information is not provided in the document. The system relies on a physical-chemical principle and an established algorithm, not a machine learning model that learns from a distinct training dataset with its own ground truth.

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