(50 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. It is of Moderate level of concern. 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.
The provided text, K220003, is a 510(k) summary for a software device called "EzOrtho v1.3." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (EzOrtho v1.2) rather than presenting a performance study with acceptance criteria and a detailed study design.
Therefore, the requested information, specifically regarding acceptance criteria, a detailed study proving device performance against these criteria, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types, is not explicitly available in the provided document.
The document states:
- "EzOrtho v1.3 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device." (Page 6)
- "The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation." (Page 6)
- "The modifications are changes in PC system requirement information, upgrading the SETTINGS tab (font size change option for analysis chart), upgrading the PATIENT Tab (reset to original DICOM pixel spacing), upgrading the VIEWER Tab (change layouts in presentation mode), upgrading the ANALYSIS Tab (exporting analysis chart), upgrading the PRACTICE Tab (UI upgrade and recurrence option).These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness." (Page 6)
- "SW verification/validation and the measurement accuracy test 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." (Page 7)
This indicates that the focus of the submission was on validating the non-significant changes between versions to ensure they did not negatively impact the established safety and effectiveness. The "measurement accuracy test" mentioned is likely a part of the software verification/validation, but its specific methodology, acceptance criteria, and detailed results are not provided in this summary.
In summary, the document does not contain the detailed performance study information requested. It primarily relies on the predicate device's established performance and demonstrates that the modifications in EzOrtho v1.3 do not alter its fundamental functionality or safety/effectiveness profile, hence requiring less extensive clinical performance data than a novel device might.
§ 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).