(15 days)
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.
The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria. The document is a 510(k) summary for the syngo TrueD Software, focusing on establishing substantial equivalence to predicate devices rather than reporting on a specific performance study against predefined acceptance criteria.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can be inferred from the text regarding performance, albeit not in the context of specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
- This information is not provided in the document. The 510(k) submission primarily focuses on the device's intended use, technological characteristics, safety information, and substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- This information is not provided in the document. No specific test set or study data is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided in the document. No mention of experts or ground truth establishment relevant to a performance study.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This information is not provided in the document. The text does not mention any MRMC study or an effect size of human readers improving with or without AI assistance. The document states: "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures." This implies the device is a tool to aid, rather than replace, human diagnosis, but no comparative study is detailed.
6. Standalone (Algorithm Only) Performance Study
- This information is not provided in the document. The document describes syngo TrueD as a "medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images," and "syngo TrueD provides analytical tools to help the user assess, and document changes..." This implies it's a tool for human review and analysis, not a standalone diagnostic algorithm with independent performance metrics.
7. Type of Ground Truth Used
- This information is not provided in the document.
8. Sample Size for the Training Set
- This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the document.
§ 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).