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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Prospective Postmarket Surveillance Study Plan


 
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General
Study Status Progress Inadequate
522 Number / Requirement Number PS110002 / PSS005
Date Current Plan Accepted 11/14/2016
Study Name Prospective Postmarket Surveillance Study Plan
Root Document Number P000023  P000035 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Design Description Prospective, single-arm, postmarket surveillance descriptive study
Study Population Description Subjects with a need for implantation of either a TMJ Fossa- Eminence and Condylar Prosthesis System or a TMJ Fossa- Eminence Prosthesis System

Sample Size A first revision rate of 7% at 5 years was used for sample size estimation. For the precision of this estimate, the margin of error for the upper limit of the confidence band was set as 3.5%. If the assumed true proportion is 7%, the sample size required for a 95% 1-tailed error margin of 3.5% is 222 subjects. With allowance for 20% loss to follow-up, 278 subjects for the Total Joint System and 278 subjects for the Partial Joint System will be enrolled.

Data Collection Primary endpoint: Time to first revision, from which the revision rates will be derived for both the Partial Joint System and the Total Joint System at 1, 2, 3, 4, and 5 years. Secondary endpoint:

• The impact of patient diagnosis on the timeframe to revision

• Time interval (in months) after initial revision to subsequent revisions

• Reasons for initial and subsequent revisions

• Association between patient demographics and/or clinical data and device failure

• Time to revision in which the Revision specifically entails revising the partial implant to a total implant



Follow-up Visits and Length of Follow-up Subjects will be recruited at participating study centers for inclusion in this study from the population of patients who present with severe TMJ disease that meets the criteria for partial or total joint reconstruction outlined in the approved indications for use.

5 years (60 months)


Prospective Postmarket Surveillance Study Plan Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/14/2016 09/16/2016 Overdue/Received
1 year report 03/16/2017 03/20/2017 Overdue/Received
18 month report 09/14/2017 02/01/2019 Overdue/Received
2 year report 03/16/2018   Overdue
3 year report 03/16/2019   Overdue
4 year report 03/15/2020   Overdue
5 year report 03/15/2021    


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