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The EM44 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 not to 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 EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EM44 Glucose Control Solution For use with EM44 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The EM44 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to 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 EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EM44 Glucose Control Solution For use with EM44 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EM44 meter and the EM44 test strips. The EM44 meter only is used with the EM44 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The system consists of the EM44 Pro meter and the EM44 Pro test strips. The EM44 Pro meter only is used with the EM44 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The provided text is a 510(k) summary from the FDA for a blood glucose monitoring system. It primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to predicate devices. It does not contain the detailed information required for an acceptance criteria table or a study description.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size, human reader improvement)
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document confirms that the device is a Blood Glucose System (EM44 Pro and EM44 Self Monitoring Blood Glucose System) intended for quantitative measurement of glucose in whole blood. It also specifies its intended use for OTC and/or Prescription Use, and that it's not for diagnosis or screening of diabetes mellitus, nor for use on neonates.

To answer your questions, I would need access to the actual study reports, performance data, and other technical documentation that typically accompanies a 510(k) submission, but is not included in this summary letter.

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