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The Finetest Lite Blood Glucose Monitoring System is comprised of Finetest Lite Blood Glucose meter and Finetest Lite Blood Glucose Testing Strips. It is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, calf and thigh. The Finetest Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Finetest Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The proposed Finetest Lite Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text is related to the FDA 510(k) clearance for the Finetest Lite Blood Glucose Monitoring System. It does not contain information about the acceptance criteria and study proving the device meets those criteria, as typically found in a clinical study report. The document primarily focuses on the regulatory submission, equivalence to a predicate device, and general performance data without specific metrics or detailed study designs.

Therefore, I cannot provide the requested table and detailed information based on the given text. The text only broadly states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This is insufficient to extract the specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, or other detailed study information.

If such information were available in a more detailed clinical study report or performance evaluation section, I would be able to extract and present it as requested.

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