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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.

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, AG-6081 Single Blood Glucose Monitoring System and AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System and AG-6951 Multi Blood Glucose Monitoring System. When used with the above Blood Glucose Monitoring Systems, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

Here's an analysis of the provided text regarding the Andon Health Care Management System Software's acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics beyond functional descriptions. The "Performance specifications, including any testing" section lists functionalities rather than measurable criteria with associated performance targets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test set or the data provenance. It only states, "Testing of Andon Health Care Management System Software included system test and unit test."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As the device is for data management and not diagnostic interpretation, it's unlikely a ground truth established by medical experts in the traditional sense would be applicable for the software's functional testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is a data management software, not an AI-powered diagnostic or assistive tool for human readers. Its purpose is to transfer, store, and display blood glucose data.

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

This refers to the software's inherent functional performance. The document states, "Testing of Andon Health Care Management System Software included system test and unit test," which implies standalone testing of the software's functions (e.g., data transfer, storage, display, printing). However, no specific details on the methodology or results of these tests are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For software like this, "ground truth" would typically refer to the expected functional behavior and data integrity. The document does not explicitly state how this ground truth was established, but it would presumably be based on software requirements and specifications (e.g., if the meter stores X data points, the software should always accurately display X data points).

8. The sample size for the training set

This information is not provided. The software described does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. It's an application for data management.

9. How the ground truth for the training set was established

Not applicable as the device is not described as an AI/machine learning model requiring a training set.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication methods for a test set.
3. Effect size of human readers with/without AI assistance.
4. Standalone algorithm performance.
5. Type of ground truth used.
6. 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.

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