CEPHX- Cephalometric Analysis Software
Orca Dental AI LTDCEPHX is a software tool designed for orthodontists that uses AI to analyze cephalometric x-ray images. It automatically identifies important anatomical landmarks on 2D x-rays, aiding in diagnosis, treatment planning, and patient consultation for individuals over 14 years old. This helps clinicians effectively monitor and simulate orthodontic treatment progress.
Intended Use
CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation on patients 14 years and older.
Technology
The software uses AI to automatically generate 99 cephalometric landmark points on 2D cephalometric x-ray images to facilitate orthodontic analysis. It provides various built-in and custom analysis tools and supports image manipulation and comprehensive treatment planning features.
Performance
Performance testing involved verification of AI-generated landmarks against manual annotations by orthodontic specialists. Results showed 99% of landmarks identified within 2.0 mm margin, meeting acceptance criteria and demonstrating high accuracy and reliability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2023
8 months - 2
FDA Approval
1/31/2024
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