(213 days)
CephNinja software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners. Mobile application is not for diagnostic use.
CephNinja is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x-ray image, trace cephalometric structures, conduct cephalometric analysis, and view cephalalometric results. CephNinja is imaging software designed for use in dentistry. The main CephNinja software functionality includes image visualization and cephalometric tracing and measurements. CephNinja is used by dental professionals for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review, and treatment planning for orthodontic and orthognathic applications. If a suitable image file (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be used to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. The software operates on standard Mac/iMac (OS Big Sur M1) hardware, and when not used for diagnostic purposes, iPhone/iPad (OS 9.0 or higher) hardware. When iMac hardware is used, images are displayed on the connected display/monitor. CephNinja is a standalone product.
The provided text describes a 510(k) premarket notification for a device named "CephNinja." The document outlines the device's intended use, technical characteristics, and a comparison to a predicate device (SmartCeph) and a reference device (Dolphin Blue Imaging 2.0). However, the document does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria in a structured format with specific performance metrics and statistical outcomes.
The section "J. Summary of Performance Testing" briefly mentions non-clinical bench testing and states that "all differences in individual angular and linear measurement values between the measurement methods must be within the clinically meaningful threshold of
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).