|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P210015 / PAS001 |
| Date Original Protocol Accepted |
10/31/2022
|
| Date Current Protocol Accepted |
10/31/2022
|
| Study Name |
Avive AED Post-Approval Study
|
| Device Name |
Avive Automated External Defibrillator (AED) System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective observational study comparing the Avive AED Rhythm Recognition Detector performance to objective performance criterion.
|
| Study Population |
N/A
|
| Sample Size |
200 cases
|
| Key Study Endpoints |
The primary study endpoint for this PAS is a >90% sensitivity on Course VF rhythms for the Avive AED, with a 90% One-sided Lower Confidence Limit that is >87%.
The following will also be reported:
-Performance on Rapid VT rhythms for the Avive AED
-Performance on Normal Sinus rhythms for the Avive AED
-Performance on Asystole rhythms for the Avive AED
-Performance on other non-shockable rhythms for the Avive AED, including Atrial Fibrillation, Supraventricular Tachycardia, Sinus Bradycardia, Heart Block, Idioventricular rhythms, and Premature Ventricular Contractions
-Performance on Fine VF for the Avive AED
-Performance on Other VT for the Avive AED
In addition to the ECG analysis performance, the PAS will also report the usability performance of the Avive AED represented by the time elapsed from AED activation to pads placed and if shockable, time to first shock delivered. These data will be extracted and reported from the same AED device log. This information provides the most objective metric of the device usability, incorporating the critical tasks that are required to provide patient treatment.
|
| Follow-up Visits and Length of Follow-up |
No follow-up required
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,909 ECG rhythm segments total. 222 ECG rhythm segments with Coarse VF.
|
| Actual Number of Sites Enrolled |
N/A
|
| Patient Follow-up Rate |
No follow-up needed in this study. Overall, the study demonstrates a 95.5% sensitivity on Coarse VF rhythms with a 90% one-sided lower confidence limit that is 93.7% across 222 collected cases.
|
| Final Safety Findings |
There were 11 instances out of 287 (3.8%) where the adjudicator consensus was either Coarse VF (10/11 instances), or Rapid VT (1/11 instances), and the AED assessed a non-shockable rhythm. None of these 11 instances had 3/3 agreement amongst the three cardiologist adjudicators. Most included a combination of shockable (Rapid VT or Coarse VF) and intermediate (Other VT or Fine VF) classifications. In 7/11 of the instances, the rhythm presented with a slow rate (<160 BPM), a low-amplitude, and semi-organized electrical activity where an Other VT, Fine VF or Pulseless Electrical Activity (PEA, which is not an option that the adjudicators can select) could have reasonably been an appropriate classification. In 10/11 of the instances, the rhythm had large deflections and/or errant QRS complexes mid-rhythm. By design, a rhythm presenting with significant indeterminate artifact can influence the AED rhythm recognition detector to not advise a shock due to safety considerations.
|
| Final Effect Findings |
The results were a 95.5% sensitivity on Coarse VF rhythms for the Avive AED, with a 90% one-sided lower confidence limit that is 93.7% across 222 collected cases.
|
| Study Strengths & Weaknesses |
The study collected data from real-world use of the Avive AED and demonstrated an acceptable performance for detection of Coarse VF and an acceptable time from power on to both pad placement and shock (if delivered). ECG segments seen by the Avive AED in the field are borderline rhythms, may be deteriorating from one arrythmia type to another, contain noise and artifact, and when viewed in an isolated 7-second segment can be interpreted differently even by board certified cardiologists.
|
| Recommendations for Labeling Changes |
None
|
