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The EM50 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood form fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is no the be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EM50 Glucose Control Solution For use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM50 Glucose Control Solution is for use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The provided document is a 510(k) premarket notification letter from the FDA for a Self-Monitoring Blood Glucose System. This document does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-based medical device.

The document primarily focuses on:

• Regulatory classification: Class II device (Glucose Test System).
• Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood for self-monitoring by diabetics at home.
• General controls and compliance: Registration, labeling, good manufacturing practices, adverse event reporting.
• Contact information for FDA offices.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document that describes:

• Performance data and study results for the EM50 Self Monitoring Blood Glucose System.
• Specific acceptance criteria for accuracy, precision, or other performance metrics of the glucose meter.
• Details about the study design, including sample size, data provenance, ground truth establishment, etc.

Since the input text describes a traditional medical device (blood glucose meter) and not an AI/ML system, concepts like "experts for ground truth," "adjudication methods," "MRMC studies," "standalone algorithm performance," and "training set" are not relevant to this document.

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