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The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

BGM039 brand of Blood Glucose Monitoring System is designed to have two variation models, BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring System is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose Monitoring System is implemented with all of the changes stated in the submission. The two meters use the same BGM039 Test Strip and Contrex Plus 4 Control Solution. This Premarket Notification (510(k)) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, K202885.

BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System consists of the blood glucose meter and single use test strips. It is used for testing of blood glucose by self-testers at home.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive summary. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing section and the overall context of a blood glucose monitoring system, we can infer some general acceptance criteria for such devices, especially concerning accuracy. The FDA's guidance for blood glucose monitoring systems generally requires specific accuracy levels.

Here's an attempt to answer your questions based on the available information and common practices for blood glucose monitoring systems, with explicit mention of where information is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., in terms of percentage agreement or mean absolute relative difference) nor does it provide a table of performance statistics for the accuracy test.

It mentions "accuracy test" in the non-clinical testing section, implying that such a test was conducted. For blood glucose meters, common acceptance criteria from standards like ISO 15197 (which is often referenced by the FDA) are:

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

• Sample Size for Test Set: Not provided. The document states "no clinical testing was conducted." While it mentions "accuracy test" as part of non-clinical testing, the sample size (number of subjects or samples tested) for this test is not specified.
• Data Provenance: Not explicitly stated. Given "no clinical testing was conducted," any "accuracy test" would likely be laboratory-based rather than from patients. If human samples were used in a lab setting, their origin (country, retrospective/prospective) is not mentioned.

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

This information is not provided. Since no clinical testing was conducted, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists, pathologists) does not directly apply here. For blood glucose meters, ground truth is typically established by a laboratory reference method (e.g., a YSI analyzer), not human expert consensus.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are relevant for studies where multiple human readers interpret data, and discrepancies need to be resolved. This is not applicable to the non-clinical testing described for a blood glucose meter where ground truth is established by a reference instrument.

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

There was no MRMC comparative effectiveness study and no mention of AI in this 510(k) submission. This type of study is not relevant for a blood glucose monitoring system, which is a diagnostic device for measuring glucose levels, not an AI-powered diagnostic imaging tool.

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

This information is not directly applicable in the context of an "algorithm only" performance as described for AI. The device itself (meter + strip) is the "algorithm" that provides the glucose measurement. The non-clinical "accuracy test" would inherently be a standalone performance evaluation of the device in a controlled setting against a reference method. The document states "no clinical testing was conducted," which implies performance was assessed without human operators collecting samples in a clinical trial setting.

7. The Type of Ground Truth Used

The most likely ground truth for an accuracy test of a blood glucose monitor is a laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated, this is standard practice for evaluating blood glucose meters. The document mentions "accuracy test" which implies comparison to a gold standard.

8. The Sample Size for the Training Set

This information is not provided. Blood glucose meters typically do not use "training sets" in the machine learning sense for their core measurement algorithm. Their performance characteristics are determined during design and manufacturing through calibration and testing. If any internal component underwent machine learning (which is unlikely but not impossible for signal processing), that information is not disclosed.

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

This information is not provided. As mentioned above, the concept of a "training set" with established ground truth as it applies to AI/ML is generally not relevant for determining the performance of a blood glucose meter.

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