User's Manual

G4-Global System User’s Guide | 139
Calibrations Stability
The G4-Global Receiver must be calibrated every 12 hours. To demonstrate
performance of the G4-Global Receiver over a 12-hour calibration period, 71
Sensors were evaluated to verify that performance remains consistent over
the 12-hour calibration period. G4-Global Receivers were evaluated in 3-hour
increments after calibration. Performance was estimated at each 3-hour interval
and stratifi ed by glucose concentrations by calculating the percentage of
G4-Global Receiver readings within 20%, 30% and greater than 40% of the YSI
readings. See the table below.
Table 8. Percentage of G4-Global Receiver readings within 20%, 30% and
40% of the YSI Laboratory reading with data stratifi ed in 3-hour increments
after calibration across days 1, 4 and 7.
Time from
Calibration
and YSI
G l u c o s e R a n g e
(40-400 mg/dL)
Number
of Paired
Readings
% of
Readings
within 20%
of YSI
% of
Readings
within 30%
of YSI
% of
Readings
within 40%
of YSI
0-3 hours 1031 77% 91% 96%
3-6 hours 345 75% 91% 96%
6-9 hours 235 71% 88% 94%
9-12 hours 187 77% 88% 91%
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results