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The Evencare® Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for use outside the body by diabetics at home and in clinical settings as an aid to monitor the effectiveness of diabetes control.

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The provided text is a 510(k) clearance letter from the FDA for a blood glucose monitoring system. It confirms substantial equivalence but does not contain specific details about the acceptance criteria, study design, or performance metrics.

Therefore, I cannot extract the requested information regarding:

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

The document primarily focuses on the regulatory clearance for the EvenCare® Blood Glucose Monitoring System, indicating it is substantially equivalent to legally marketed predicate devices for the quantitative measurement of glucose in fresh capillary whole blood for diabetic monitoring.

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