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The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system.

The FORA POCT Management System may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional.

The FORA POCT Management System is designed for using in hospital or health institute environment. The system provides management on quality control data, Blood Glucose Measurement, Stock Control, Meter Setting, Operator and Operation Units with multiple reporting options and tools.

The information uploaded from meters is arranged and analyzed by graphs and summarizes tables according to various groups of functions. It allows the user to make management and improvement decisions more effectively.

Through evaluation of the historical test results, healthcare professionals can do health management effectively.

The provided text indicates in Section 7 that "Testing of FORA POCT Management System indicates that the system meets the acceptable criteria." However, it does not provide any specific details regarding what those acceptance criteria are, what studies were performed, or any performance metrics.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I answer points 2 through 9, as the necessary information is not present in the provided document.

To answer your request, more detailed information about the performance studies would be required, typically found in a dedicated performance study report or other sections of a 510(k) submission that are not included here. This document is a 510(k) Summary, which often provides a high-level overview rather than granular study details.

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