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Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.

The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.

Overjet Periapical Radiolucency "PARL" Assist is a module within the Overjet Platform. The Overjet PARL Assist (OPA) software automatically detects periapical radiolucency on periapical radiographs. It is intended to aid dentists in the detection of periapical radiolucency. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by professionally trained and licensed dentists. Overjet PARL Assist is a software-only device which operates in three layers: a Network Layer, aPresentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

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