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The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

The provided text includes a 510(k) summary for the "EZ Smart Blood Glucose Monitoring System," specifically for an additional labeling and indication for alternative site testing. However, it explicitly states that there has been no change to the performance characteristics or fundamental scientific technology of the device system.

Therefore, the document does not contain details about a study to prove new acceptance criteria related to its performance, an MRMC study, or a standalone algorithm performance study. The focus of this 510(k) is solely on labeling changes for alternative site testing.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what cannot be found:

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

This information is not provided in the document. The submission focuses on labeling changes, stating "There has been no change to the performance characteristics of the device system." Therefore, no new performance data or acceptance criteria related to a new study are included.

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

This information is not provided as no new performance study was conducted for this 510(k) submission.

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

This information is not provided as no new performance study was conducted.

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

This information is not provided as no new performance study was conducted.

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:

An MRMC study was not done. The device is a "Blood Glucose Monitoring System," which is an instrument for measuring glucose, not an AI-assisted diagnostic tool that would involve human readers.

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

A standalone performance study of an algorithm was not done. This device is a blood glucose monitoring system, not an algorithmic diagnostic tool. The submission explicitly states "There has been no changes to the fundamental scientific technology," implying no new algorithm or AI components.

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

This information is not provided as no new performance study was conducted for this 510(k) submission. For a blood glucose monitoring system, ground truth would typically be established against a laboratory reference method.

8. The sample size for the training set:

This information is not provided as no new performance study was conducted and there is no mention of a "training set" in the context of this device's technology.

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

This information is not provided as no new performance study was conducted and there is no mention of a "training set."

In summary, the provided 510(k) submission focuses solely on updating the labeling for the EZ Smart Blood Glucose Monitoring System to include alternative site testing. It explicitly states that there are no changes to the device's performance characteristics or fundamental scientific technology. Therefore, the document does not contain information about new acceptance criteria, a new study to prove device performance, or details regarding test sets, experts, or ground truth establishment.

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