(121 days)
Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:
The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.
The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.
The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.
The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.
The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.
The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.
The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.
The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.
The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.
The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.
The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.
Effective Z and electron density maps may aid in the differentiation of different tissues in the human body.
Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis. The Dual Energy applications are being replaced by Spectral Stone Analysis and Spectral Composition Analysis. These applications, along with Spectral Analysis, utilize DiCOM data acquired by the Spectral Scan System from the scanner, K192828.
The provided document describes the Vitrea Software Package, VSTP-001A, specifically detailing the performance testing for its new "Spectral" features: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance in narrative form rather than explicit quantitative acceptance criteria. However, based on the descriptions, we can infer the criteria and reported performance for the new Spectral features:
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Spectral Stone Analysis | Ability to differentiate uric acid stones from other stones. | "A study was conducted using a phantom with various kidney stones and it was determined that the feature demonstrated the ability to differentiate uric acid stones from other stones." |
| Spectral Composition Analysis | Ability to extract gout (monosodium urate) and display the extracted value. | "A study was conducted using a hand phantom with various concentrations of monosodium urate. The results demonstrate the feature's ability to extract gout as well as display the extracted monosodium urate value." |
| Spectral Analysis | Ability to: |
- Effectively generate iodine maps.
- Measure and display iodine concentration.
- Measure Effective Z value.
- Perform subtraction of iodine in Virtual Non-Contrast (VNC) images.
- Generate monochromatic images.
- Produce electron density images. | "This application is comprised of several features which were tested using various phantoms in order to demonstrate their ability to perform their intended functionality. Phantoms with various concentrations of iodine were utilized to asses the effective generation of iodine maps, the measurement and display of iodine concentration, the measurement of the Effective Z value and the subtraction of iodine in virtual non-contrast (VNC) images. Phantom studies were also conducted to evaluate the generation of monochromatic images and the ability to produce electron density images, as derived from measurements of known objects embedded in the phantoms. As determined by the results of each of these tests, Spectral Analysis demonstrates the ability to perform as intended across all evaluated criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the studies were conducted using phantoms. This suggests:
- Sample Size: Not explicitly stated in terms of number of cases, but "various kidney stones" and "various concentrations of monosodium urate" and "various concentrations of iodine" imply a range of test conditions within the phantom studies. The exact number of phantom configurations or measurements is not provided.
- Data Provenance: The data is based on bench testing with phantoms, rather than human patient data. It is not specified if any real-world patient data was used for testing these specific spectral features. The country of origin for the phantom data is not specified but the submitter is Canon Medical Systems Corporation, Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for these phantom studies would be the known physical properties of the materials within the phantoms (e.g., actual composition of stones, known concentrations of monosodium urate, known iodine concentrations, known effective Z values, known electron densities). Therefore, human experts were likely not used to establish the ground truth for these specific phantom tests; rather, the phantoms themselves served as the "ground truth" based on their construction and known material properties. No information on human experts establishing ground truth is provided.
4. Adjudication Method for the Test Set
Given that the testing involved phantoms with known physical properties serving as the ground truth, an adjudication method for human interpretation is not applicable. The device's output would be compared directly to the known phantom properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for the new Spectral features based on the provided text. The testing described focuses on the standalone performance of the algorithms using phantoms.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone (algorithm only) performance testing was done. The descriptions of the studies for Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis clearly indicate that the device's ability to differentiate, extract, display, generate, and measure was evaluated based on phantom studies, without mentioning human readers in the loop for these specific performance evaluations.
7. The Type of Ground Truth Used
The type of ground truth used was known physical properties/composition of phantoms.
- For Spectral Stone Analysis: Known types of kidney stones (uric acid vs. non-uric acid).
- For Spectral Composition Analysis: Known concentrations of monosodium urate in a hand phantom.
- For Spectral Analysis: Known concentrations of iodine, known effective Z values, and known electron densities of objects embedded in phantoms.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set for these algorithms.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
§ 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).