Device Information
Indications
CEPHX – Cephalometric Analysis Software is designed for dentists providing orthodontic treatment. It assists in image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. The software is intended for use on patients 14 years and older. Results depend on interpretation by trained and licensed practitioners.
Intended Use
The software is to be used by qualified dentists.
Limitations
The software is only for use on patients 14 years of age and older. Results depend on licensed practitioners and are not a substitute for professional clinical judgment.
Study Results
A study verified the accuracy of AI-generated landmarks in cephalometric tracing against manual landmarks provided by orthodontic specialists. The results showed 99% accuracy, meeting the study’s predefined hypothesis. The software demonstrated high reliability and precision.
Regulatory Information
The device is classified as a Class II medical device under 21 CFR 892.2050 and must comply with applicable regulatory requirements, including quality system regulations and good manufacturing practices.
Manufacturer Information
- Manufacturer: Orca Dental AI Ltd.
- Address: 10 Hamanofim Street, Herzliya, PO 4672561, Israel
- Primary Contact: Daniel Abraham, CEO
Predicate Device Information
- Predicate Device Name: WebCeph(510K No: K220903)
- The predicate device shares similar technological characteristics and intended use but is indicated for patients aged 7 years and older.
Implications
The CEPHX software provides an advanced tool for orthodontic treatment, enhancing accuracy in cephalometric analysis. It does not replace clinical judgment but serves as a reliable aid in diagnosis and treatment planning.
References
- CEPHX – Cephalometric Analysis Software. K231396. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231396
- https://www.orca-ai.com/solutions/orthodontics/
- https://cephx.com/
Medevx 