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The EasyPlus mini R13N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini R13N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The EasyPlus mini R13N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R13N Blood Glucose Test Strips must be used with the EasyPlus mini R13N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

EasyPlus mini R13N Glucose Control Solutions For the use with EasyPlus mini R13N meter and EasyPlus mini R13N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

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The provided text is a 510(k) premarket notification from the FDA for a blood glucose monitoring system, the "EasyPlus mini R13N Self-Monitoring Blood Glucose System." It primarily addresses regulatory aspects, substantial equivalence, and indications for use.

Crucially, this document does not contain the detailed study results, acceptance criteria, or an analysis of device performance that would be required to answer your specific questions. It confirms the device's clearance based on substantial equivalence to existing devices but does not provide the underlying performance data from the validation studies.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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-based imaging or diagnostic device involving human readers in that capacity. Therefore, an MRMC study as described would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: While the device itself is a standalone measurement system, the details of its performance study as "algorithm only" are not provided.
7. The type of ground truth used: Not explicitly stated, though for a blood glucose monitor, ground truth would typically be established by a reference laboratory method.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) letter is a regulatory clearance document. It does not include the technical details of the performance study that would show how the device meets specific acceptance criteria. To answer your questions, you would need to access the actual performance study report that was submitted to the FDA as part of the 510(k) application.

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