Avive AED - Page 26

IFU-00367 Rev A
26
Convolution Neural Network Algorithm for Shockable Arrhythmia Classification Within A Next-Generation
Automated External Defibrillator” was published and presented at the American College of Cardiology.
The performance of the Rhythm Recognition Detector exceeds sensitivity and specificity recommendations of
the American Heart Association, and the requirements set forth by IEC 60601-2-4. Performance results for the
algorithm are summarized below.
Rhythm
Test Sample Size
Observed Performance
Performance Goal
90% One-Sided Lower
Confidence Limit
Shockable
Coarse V-Fib
274
98.9% sensitivity
>90% sensitivity
97.9%
Rapid V-Tach
101
99.0% sensitivity
>75% sensitivity
97.4%
Non-Shockable
NSR
137
100% specificity
>99% specificity
100%
AF, SB, SVT,
Blockage,
Idioventricular,
PVC’s
288
99.3% specificity
>95% specificity
98.5%
Asystole
105
100% specificity
>95% specificity
100%
Intermediate
Fine VF
80
92.5% Shock
Report Only
-
Other VT
66
86.4% Shock
Report Only
-
Defibrillation Waveform
The Avive AEDä delivers an impedance-compensating, biphasic
truncated exponential (BTE) waveform configurable for both adult
and pediatric therapy. The waveform dynamically adjusts to
optimize energy delivery to a wide range of patient impedances.
Both the adult and pediatric waveforms use a non-escalating energy
delivery protocol of 150 Joules and 50 Joules respectively.
Nominal Adult Values
Nominal Pediatric Values
Impedance (Ω)
Delivered
Energy (J)
Phase 1
Duration (ms)
Phase 2
Duration (ms)
Delivered
Energy (J)
Phase 1
Duration (ms)
Phase 2
Duration (ms)
25
139.8
2.6
2.4
48.3
2.2
2.0
50
146.9
4.4
3.7
50.1
3.7
2.9
75
148.6
6.5
4.4
49.9
4.8
3.6
100
149.8
8.5
5.5
49.2
5.8
4.1
125
150.6
10.6
6.8
48.4
6.6
4.6
150
148.6
11.4
6.8
47.4
7.4
5.0
175
145.0
11.4
6.8
46.0
7.7
5.3
200
140.8
11.4
6.8
43.9
7.7
5.3