(127 days)
MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meter and MEG-2B Test Strips. It is used for testing of blood glucose by self-testers at home. The MEG-2B Pro Blood Glucose Monitoring System consists of the MEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The MEG-2B and MEG-2B Pro systems are identical other than trade names and details of product labeling.
This document is a 510(k) premarket notification for a blood glucose monitoring system, and as such, it does not contain the detailed information about acceptance criteria and a study design that you would typically find for an AI/ML-based medical device. The device in question is a physical blood glucose meter, and the changes discussed are related to manufacturing and disinfectants, not a software algorithm or AI.
Therefore, I cannot extract the information requested for the following reasons:
- No Acceptance Criteria for AI/ML performance: The document describes a blood glucose monitoring system, not an AI/ML device. Acceptance criteria discussed would relate to accuracy of glucose measurements, not AI performance metrics like sensitivity, specificity, or AUC.
- No "Study" as defined for AI/ML: The "studies" mentioned are "Disinfection (viral inactivation) and 'robustness' testing," which are physical/chemical engineering tests, not clinical studies for AI/ML performance. It explicitly states, "No clinical testing was conducted."
- No data on training/test sets, ground truth, experts, or MRMC studies: These concepts are entirely irrelevant to the type of device and the submission described.
The prompt specifically asks for details related to an AI/ML device's validation. This document is about a different class of medical device (in vitro diagnostic glucose meter) and its physical modifications.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.