User Manual Part 4

CLINICAL STUDY - SUMMARY OF GDT1000 SEN
SING ACUTE STUDY
H-5
sensed events (223 undersense and 833 oversens e events). The sens ing
algorithm used in the first phase achieved the sensitivities , spe cificities, positive
predictive values (PPV), rates of undersensing (1-sensitivity), and rates of
oversensing (1-PPV) are summarized in the table below (Table H-3 on page
H-5).
Tab le H-3. Summary of Sensing Pe rform ance - First Phase
Sensitivity
(Rate o f
Undersensing)
Specificity
Positive
Predictive
Value
(Rate of
Oversensing)
Appropriate
Sensed
Beats
Inappropriate
Sensed
Beats:
Undersense
Inappropriate
Sensed
Beats:
Oversense
Right Atrial
Channel
100% (0%) 96.81% 97.03%
(2.97%)
19,478 0 615
Right
Ventricular
Channel
100% (0%) 98.94% 98.86%
(1.14%)
18,439 0 216
Left
Ventricular
Channel
98.63%
(1.37%)
99.99% 99.99%
(0.01%)
16,054 223 2
Totals 54,1 51 223 833
In the second phase of the study, a total of 35,998 signals were recorded
including 35,831 appropriate sensed intrinsic and paced beats and 171
inappropriate sensed events (2 undersense and 169 oversense events).
The upgraded sensing algorithm used in the second phase achieved
the sensitivities, specifi cities, positive predictive values (PPV), rates of
undersensing (1-sensitivity), and rates of o versensing (1-PPV) summarized in
the table below; the table also summarizes the results of the analysis from the
second phase (Table H-4 on page H-5).
Tab le H-4. Summary of Sensing Perform ance - Second Phase
Sensitivity
(Rate o f
Undersensing)
Specificity
Positive
Predictive
Value
(Rate of
Oversensing)
Appropriate
Sensed
Beats
Inappropriate
Sensed
Beats:
Undersense
Inappropriate
Sensed
Beats:
Oversense
Right Atrial
Channel
100% (0%) 98.64% 98.54%
(1.46%)
11,372 0 168
Right
Ventricular
Channel
100% (0%) 100% 100% (0%)
12,230 0 0
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