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The BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto diagnostic use), It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.

The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose. The BGM014 Pro blood glucose meter and BGM014 Pro test strips are used for professional testing of blood glucose.

The provided text describes the BGM014 Blood Glucose Monitoring System and BGM014 Pro Blood Glucose Monitoring System. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it implicitly indicates that the device's performance must demonstrate "substantial equivalence to the predicate system" based on various tests. For blood glucose monitoring systems, this typically aligns with accuracy standards set by organizations like ISO or FDA guidance documents. The study results are reported as meeting this substantial equivalence.

Implied Acceptance Criteria (based on common standards for blood glucose meters) and Reported Device Performance:

Study Details:

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

   • The document states: "An accuracy study was conducted with home users and professional users using finger, palm and forearm capillary whole blood. Venous blood testing was also done by the professional users."
   • However, the specific sample sizes for the test sets are not provided in the given text.
   • The data provenance (e.g., country of origin, retrospective or prospective) for the clinical study is not explicitly stated. It's implied to be prospective as it's an "accuracy study conducted with home users and professional users."

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

   • This information is not provided in the text. For blood glucose monitoring systems, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by "experts" in the sense of radiologists.

3. Adjudication method for the test set:

   • This information is not provided as it's not typically relevant for blood glucose meter accuracy studies where direct comparison to a reference method is used.

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 a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. Therefore, a MRMC comparative effectiveness study is not applicable and was not performed.

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

   • The device functions as a standalone blood glucose meter. The "accuracy study" inherently represents the standalone performance of the device without human interpretation (beyond the user applying the blood sample and reading the displayed result).

6. The type of ground truth used:

   • While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., a YSI analyzer) which is considered highly accurate.

7. The sample size for the training set:

   • This is a medical device for measuring blood glucose, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable.

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

   • Not applicable, as there is no "training set."

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