Powerheart® AED G3 Elite 9790A and 9790E
70-02053-31 A
2-5
Summary of clinical studies
The final order, Effective Date of Requirement for Premarket
Approval for Automated External Defibrillator Systems, published
on January 29, 2015 and republished on February 3, 2015, states
that clinical study information can be leveraged for AEDs from
both published studies and clinical data previously submitted
to FDA under the 510(k) Premarket Notification process. Cardiac
Science submitted the following clinical studies for the original
FDA Clearance of the Cardiac Science AEDs.
The RhythmX® ECG Analysis and STAR® Biphasic defibrillation
waveform were tested during two (2) separate clinical studies,
IDE G920078 and IDE G970230.
The RhythmX® ECG Analysis and STAR® Biphasic
defibrillation waveform, IDE G920078
Study objective:
To prove the efficacy of the RhythmX ECG
analysis using the Powerheart® Automated External Cardioverter
Defibrillator (AECD) device, which uses the exact same RhythmX
technology as Cardiac Science’s current AEDs.
Method:
The study was divided into two (2) phases: Phase I and
Phase II. Phase I was further divided into two (2) sub-phases. In
Phase I, the Powerheart® AED operated as an arrhythmia detector
only, and did not deliver shock therapy. Phase I was not randomized.
In Phase II, the Powerheart® AED operated as an arrhythmia
detector and optionally delivered shock therapy. Phase II was a
blind, randomized trial.
Results:
A total of 156 patients were enrolled in the trials. Data
from the first 15 patients was excluded because the arrhythmia
detection algorithm changed after they were studied. The
remaining 141 patients experienced 92 shockable episodes,
with 117 patients attached to the Powerheart® AED, and the
remaining 24 randomized to the standard of care only. The
sensitivity of the Powerheart® AED was 100.0%, the positive
predictivity was 93.3%, and the specificity was 99.4%. Table 2-1
shows the clinical data of all patients with 95% lower confidence
limit scores when attached to the Powerheart® AED.
Conclusion:
These data support the conclusion that Powerheart®
AEDs accurately detect ventricular tachyarrhythmias and provide
appropriate therapy according to physician selected parameters.
Introduction
