(84 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 multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following 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 DE 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 3mm with Dual Energy CT studies.
The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.
Embolization Plan is a post processing software that is intended to assist physicians in the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT (INFX-8000 Interventional Family) 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.
Vitrea Software Package, VSTP-001A, 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, Sure Volume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.
Here's a breakdown of the acceptance criteria and study information for the Dual Energy Stone Analysis and Embolization Plan applications, based on the provided text.
Dual Energy Stone Analysis
The device is the "Vitrea Software Package: DE Stone Analysis". The study demonstrates substantial equivalence to "Aquilion Dual Energy System Package" (K132813).
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Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Intended Use: Differentiation between uric acid and non-uric acid stones greater than 3mm. Subject Device (Vitrea Software Package: DE Stone Analysis): Intended to serve as an adjunct visualization
tool for the differentiation between uric acid and non-uric
acid stones greater than 3mm with Dual Energy CT studies.
Predicate Device (Aquilion Dual Energy System Package): The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm... is provided with the Dual Energy
system. When used by a qualified physician, a potential application is to determine the course of treatment. |
| Anatomical Region: Whole body. | Both Subject and Predicate devices are indicated for whole body. |
| Feature: Image Processing - Visualization of differentiation between uric acid and non-uric acid stones. | Subject Device: Image Processing - Visualization of the differentiation between uric acid and non-uric acid stones.
Predicate Device: Image Processing - Visualization of the differentiation between Uric Acid and non-uric acid stones. |
| Image data format for image processing: DICOM format of CT image data. | Subject Device: DICOM format of CT image data.
Predicate Device: Original format of CT image data (implicitly compatible with the system generating it). |
| Reconstruction/Viewing: MPR. | Subject Device: MPR.
Predicate Device: MPR / 3D (MPR in DE Stone Analysis). |
| Segmentation: The region included in the range of set CT numbers is extracted. | Subject Device: The region included in the range of set CT numbers is extracted.
Predicate Device: The region included in the range of set CT numbers is extracted. The compositions is extracted based on the composition setting. |
| Overall: Substantially equivalent performance to the predicate device. | Bench studies were conducted using sample data sets from the predicate device verification activities (K131823) and verifying that the outputs for both devices were substantially the same. |
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Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated, but the studies used "sample data sets from the predicate device verification activities (K131823)."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "predicate device verification activities," which might imply clinical data, but its nature isn't detailed.
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Number of Experts and Qualifications: Not specified for this particular application.
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Adjudication Method: Not specified.
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MRMC Comparative Effectiveness Study: No, the text describes bench testing comparing outputs, not a human reader study.
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Standalone Performance: Yes, the described "bench testing" compared the outputs of the subject and predicate devices, which implies standalone algorithmic performance.
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Type of Ground Truth: The ground truth for this comparison was "outputs for both devices were substantially the same" when processed with the same input data. It implies a comparison against the predicate device's output as a form of "ground truth" or reference, rather than an independent gold standard like pathology.
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Training Set Sample Size: Not specified.
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Ground Truth for Training Set: Not specified.
Embolization Plan
The device is the "Embolization Plan" software application. The study demonstrates substantial equivalence to "Philips EmboGuide" (K142273).
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Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Intended Use: Assist physicians in visualization and planning of liver arterial vessels for embolization procedures, using 3D images of CT or Cone Beam CT, and guiding embolization.
(Primary function: determining feeder vessels). | Subject Device (Embolization Plan): ...intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT... 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.
Predicate Device (EmboGuide): ...intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure. |
| Anatomical Region: Liver. | Both Subject and Predicate devices are indicated for the liver anatomical region. |
| Input: 3D images (CBCT for predicate). | Subject Device: CT / CBCT.
Predicate Device: CBCT. (Note: The subject device expands input compatibility). |
| Reconstruction/Viewing: MPR / 3D. | Both Subject and Predicate devices support MPR / 3D. |
| Vessel tracking: Automatic/Manual. | Both Subject and Predicate devices support automatic/manual vessel tracking. |
| Distance measurement: Manual. | Both Subject and Predicate devices support manual distance measurement. |
| Overall: Effective in assisting clinicians to identify the required feeder vessels for embolization planning. | The resulting performance data demonstrated that the software was effective in assisting clinicians to identify the required feeder vessels for embolization planning. |
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Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: "sample data that was obtained from clinical institutions where local ethical controls were in place." This suggests retrospective clinical data, but the countries of origin are not specified.
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Number of Experts and Qualifications: Not specified for this particular application.
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Adjudication Method: "The data was reviewed and verified independently by a test group and a control group." This suggests an independent review, but the specific adjudication rules (e.g., 2+1) are not detailed.
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MRMC Comparative Effectiveness Study: The study involved a "test group and a control group" reviewing data, and the device's effectiveness in "assisting clinicians" was evaluated. This implies a human-in-the-loop study, but the "effect size of how much human readers improve with AI vs without AI assistance" is not quantified in the provided text. It only states that the software "was effective in assisting clinicians."
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Standalone Performance: While the software has standalone features, the referenced study explicitly evaluates its performance in "assisting clinicians," indicating a human-in-the-loop context. No purely standalone performance metrics are provided.
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Type of Ground Truth: The ground truth was implicitly established through review and verification by the "test group and a control group" from clinical institutions. This suggests expert consensus based on clinical data.
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Training Set Sample Size: Not specified.
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Ground Truth for Training Set: Not specified.
§ 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).