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Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Reconfirmation Analysis Mode Algorithm


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General
Study Status Study Pending
Application Number P160022 / PAS001
Study Name OSB Lead-Reconfirmation Analysis Mode Algorithm
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective observational study with newly enrolled patients.

The purpose of this study is to prospectively validate the RAM algorithm by comparing the performance of the RAM algorithm to the performance goals recommended by the American Heart Association (AHA).
Study Population Description Subjects are enrolled in this study when they are found in cardiac arrest and receive attempted resuscitation by participating EMS agencies and treatment with the ZOLL X-Series defibrillator. Subjects meeting the labeled indications for use will be recruited into the study with the following inclusion and exclusion criteria based on the current labeling for X-Series.

Inclusion Criteria:

Candidates for this study must meet all of the following criteria:

1. Age greater than or equal to 8 years and weight greater than or equal to 55 pounds (25 kg)

2. Out-of-hospital cardiac arrest (OOHCA)

3. Non-traumatic arrest

Exclusion Criteria:

Candidates will be excluded from the study if any of the

following conditions are present:

1. Weight less than 55 pounds (25 kg)

2. Do-not-attempt-resuscitation (DNAR) orders.
Sample Size Approximately 2500 subjects are planned to be enrolled in the study to provide adequate data for all rhythms in the final analysis. Currently, the rate limiting rhythm is anticipated to be Rapid VT as it quickly degrades to VF and is rare to capture in waveform data. Historically, only 2% of all rhythms assessed in previous datasets were categorized as rapid VT. To satisfy the minimum of 50 subjects for rapid VT, 2500 subjects will be enrolled.

Based on Kerber’s sample size and performance goals listed in the Kerber et al. 1997 article referred above, the following minimum sample sizes for five different categories of rhythm will be required for this study.

For Coarse VF,

When the sample size is 200, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.027 from the observed proportion for an expected proportion of 0.900.

For Rapid VT

When the sample size is 50, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.078 from the observed proportion for an expected proportion of 0.750.

For Non-Shockable Rhythm

When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.013 from the observed proportion for an expected proportion of 0.990.

For Other Non-Shockable Rhythms (AF, SB, SVT, PVCs)

When the sample size is 30, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.051 from the observed proportion for an expected proportion of 0.950.

For Asystole

When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.028 from the observed proportion for an expected proportion of 0.950.
Data Collection The primary endpoint is the accuracy of the RAM algorithm (i.e., measured as sensitivity for shockable rhythms and specificity for non-shockable rhythms for the algorithm) compared to manual annotation for each rhythm type.

Primary outcome measure:

ECG data files will be manually annotated as shockable or non-shockable by two (2) non-physician experts in ECG cardiac rhythm analysis and one (1) physician expert in ECG analysis. This annotation will be based on the ECG waveform immediately following the end of the CPR compression interval only; that is, the annotation will be done only with the portion of the ECG waveform that is free from CPR artifact. The shock determination decision reached by the cardiac monitor will be compared with the manual annotations of the same ECG data by the three (3) experts.
Follow-up Visits and Length of Follow-up No follow-up visits


OSB Lead-Reconfirmation Analysis Mode Algorithm Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/27/2018    
one year report 12/27/2018    
18 month report 06/27/2019    
two year report 12/27/2019    
threee year report 12/26/2020    
four year report 12/26/2021    
final report 07/27/2023    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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