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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.

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The ORTHOGONAL TM Electrophysiology Catheters are used forelectrogram recording and cardiac stimulation during diagnosticelectrophysiologic studies. The electrophysiology catheters arecommonly placed at the high right atrium, right ventricular apex,and His bundle.

The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the ORTHOGONAL™ Steerable Electrophysiology Catheter System. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the way a medical device typically would for a de novo or PMA submission.

Therefore, the information requested in the prompt, such as specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document states: "The components of the ORTHOGONAL™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished ORTHOGONAL™ Steerable Electrophysiology Catheter has passed the performance tests."

This indicates that various performance tests were conducted, but the specific details, acceptance criteria, and results are not included in this summary. The FDA's 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, meaning that the new device is as safe and effective as the predicate. The "performance tests" mentioned are likely related to demonstrating this equivalence through bench testing (e.g., biocompatibility, sterilization validation, electrical performance, physical integrity) rather than a clinical study with statistical acceptance criteria for diagnostic accuracy as might be found in AI/imaging devices.

Based on the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth establishment. The document does not contain the level of detail required for these points.

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