(344 days)
Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The AG-608 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULT1 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
The AG-608 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-608 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System. When used with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.
The provided text describes the 510(k) submission for the "Andon Health Care Management System Software" and its associated blood glucose monitoring systems. However, it does not contain detailed acceptance criteria and the results of a study designed to prove the device meets these criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy against a well-defined ground truth with sample sizes, expert qualifications, and adjudication methods for AI/software performance).
The submission focuses primarily on demonstrating substantial equivalence to a predicate device ("Clever Chek Health Care System Software") based on shared technological characteristics and intended use. The "Performance summary" section (8.0) simply states: "Testing of Andon Health Care Management System Software included system test and unit test," which is insufficient to extract the requested information.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication methods for a test set.
- Effect size of human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document is a regulatory submission for a data management software accessory for blood glucose monitors, not an AI/ML device requiring rigorous clinical performance studies against a diagnostic ground truth. The "testing" mentioned is likely related to software functionality and safety, rather than diagnostic accuracy.
§ 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.