(14 days)
OrthoGon is a pluq-in software application for PACS workstations. The package is indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities.
OrthoGon is intended for use in the fields of musculoskeletal radiology. orthopedics, traumatology and pediatrics using 2D X-ray images based on DICOM standards.
The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.
OrthoGon assists physicians in their analysis of anatomy and pathology by providing easy to use, interactive measurement schemes.
OrthoGon allows the user to easily perform standard measurements and to compare results to prior measurements and to normal values from the medical literature.
OrthoGon uses X-ray images based on the DICOM standards. The device is compatible with multiple PACS workstations and software versions.
OrthoGon allows the user export results into Excel formatted reports.
The provided K073271 510(k) summary for Agfa OrthoGon does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The document describes Agfa OrthoGon as a software device intended to assist physicians in analyzing anatomy and pathology by providing interactive 2D measurement schemes. It asserts that OrthoGon is substantially equivalent to two predicate devices (Agfa's Orthopedic Software for Impax® Workstations (K071972) and OrthoCrat Limited's TraumaCAD (K042816)).
The "F. TESTING" section simply states: "OrthoGon has been tested for compatibility with Agfa's Impax® PACS Systems." This is a compatibility test, not a performance study evaluating acceptance criteria for diagnostic accuracy or measurement precision.
Therefore, I cannot provide the requested information, as it is not present in the provided text. The document focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and compatibility, rather than presenting a performance study with defined acceptance criteria and results.
§ 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).