(22 days)
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
EzOrtho is a 2D orthodontic analysis and simulation program developed by Ewoosoft. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.
EzOrtho is designed to provide a simple and straightforward user interface.
- Managing Patients and Registering Images ● EzOrtho offers features for making schedules and managing patient appointments. In addition. EzOrtho enables the users to import images from EzDent-i made by our company, Explorer, or a scanner, and easily calibrate the size of the image or arrange multiple film/photo images.
- . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface features support easier tracing.
- Establishing Treatment Plans ● The Morphing feature enables the user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the user to establish a treatment plan by comparing photos before and after the treatment.
- Assisting with Patient Consultation ● EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays after surgery changes visually, and the Gallery feature plays a slide show with multiple images of patients.
The provided text is a 510(k) summary for the medical device EzOrtho. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any performance data from a specific study that demonstrates the device meets particular acceptance criteria. The "Performance Data" section only states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This is a general statement and does not provide the specific details required to answer your questions about acceptance criteria and a study proving their fulfillment.
Therefore, I cannot populate the table or provide the detailed information requested regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.
To answer your questions, I would need a section detailing a specific clinical or performance study, including:
- Specific performance metrics and their acceptance thresholds.
- The actual results of the device against those metrics.
- Details about the dataset used (size, type, origin).
- Information about the ground truth establishment process (number/qualifications of experts, adjudication).
Without this specific performance study data, I can only provide general information based on the document's structure, which states that performance, functionality, and reliability characteristics were verified and validated, and all tests passed their pre-determined criteria.
§ 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).