AudaxCeph Cephalogram Analysis Software

AudaxCeph Cephalogram Analysis Software is a dental imaging software designed for use by specialty dental professionals to store and present patient cephalogram images and assist in orthodontic treatment planning. The software enables landmark digitization, structure tracing, measurements, image superimposition, growth forecasting, and treatment simulation (VTO) to support clinical decision-making by trained and licensed practitioners.

Both the subject device and predicate (CephX) perform cephalometric landmark analysis and treatment planning using computer software. Key differences: AudaxCeph supports both desktop (PC-based standalone) and cloud-hosted configurations versus predicate's cloud-only; AudaxCeph identifies 60 landmarks versus predicate's 21; AudaxCeph removes the predicate's age restriction (14+ years) and has broader intended user scope ('specialized dental practices' versus 'dentists who provide orthodontic treatment'). All core analysis capabilities (2D tracing, measurements, superimposition, growth forecast, treatment simulation, custom analysis) are present in both devices.

IEC 62304 ed. 1.1 (medical device software life cycle), IEC 62366-1 ed. 1.1 (usability engineering), ISO 14971:2019 (risk management), IEC TR 80002-1 ed. 1.0 (ISO 14971 guidance for software), FDA Cybersecurity Guidance (09-27-2023), and AAMI TIR57:2016 (medical device security). Software verification included unit, performance, manual, integration, and system/regression testing.

The devices share identical fundamental technological principles and intended use: both digitize cephalometric landmarks and provide treatment planning tools via software. The added capability of desktop hosting and increased landmark count (60 vs. 21) do not raise new safety or effectiveness questions because all clinical decision-support features remain equivalent and the additional landmarks expand utility without changing the core function. Removal of the age restriction is consistent with market practice and literature supporting analysis validity in mixed-dentition patients. Both underwent similar verification/validation per FDA-recognized consensus standards, and automatic landmark detection accuracy met predetermined acceptance criteria, demonstrating safety and effectiveness equivalent to the predicate.