(26 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 interchanges of multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications:
The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation 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.
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 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 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.
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.
This document is a 510(k) premarket notification for the Vitrea Software Package, VSTP-001A, by Canon Medical Systems Corporation. It describes several applications within the package, but the provided text focuses on the comparative studies for Dual Energy Stone Analysis, Dual Energy Composition Analysis, and Embolization Plan.
Here's an analysis of the acceptance criteria and study information for these specific applications, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the new applications. Instead, it relies on demonstrating substantial equivalence to predicate devices. For the Dual Energy applications, the key acceptance criterion appears to be that the subject device performs in a manner similar to and is intended for the same use as the previously cleared Aquilion Dual Energy Software, and utilizes the same formulas, algorithms, and measurements. For the Embolization Plan, the acceptance criterion is the same intended use as the Philips EmboGuide software and its effectiveness in assisting clinicians to identify the required feeder vessels for embolization planning.
| Application | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dual Energy Stone Analysis | Performance similar to and same intended use as predicate (Aquilion Dual Energy System Package, K132813): adjunct visualization tool for differentiation between uric acid and non-uric acid stones > 3mm with Dual Energy CT studies. Uses same formulas, algorithms, and measurements. | Bench studies verified that the outputs for both the subject device and the predicate device (from K131823 activities) were substantially the same. The subject device is a "porting of this software" with modifications to GUI and image acquisition from Vitrea Image Database (DiCOM). |
| Dual Energy Composition Analysis | Performance similar to and same intended use as predicate (Aquilion Dual Energy System Package, K132813): adjunct visualization tool for uric acid presence within surrounding anatomical structures with Dual Energy CT studies. Uses same formulas, algorithms, and measurements. | Bench studies verified that the outputs for both the subject device and the predicate device (from K131823 activities) were substantially the same. The subject device is a "porting of this software" with modifications to GUI and image acquisition from Vitrea Image Database (DiCOM). |
| Embolization Plan | Same intended use as predicate (Philips EmboGuide, K142273): assist physicians in visualization of the liver arterial tree using 3D images of CT or Cone Beam CT for planning and guidance of embolization procedures, identifying feeder vessels to high dense lesions in the liver. Must be effective in assisting clinicians to identify the required feeder vessels for embolization planning. The main difference is the inclusion of the ability to use DICOM data and CBCT data (subject) vs. CBCT data only (predicate). | Effective in assisting clinicians to identify the required feeder vessels for embolization planning. |
Study Details
The document details separate verification activities for the Dual Energy applications and the Embolization Plan.
Dual Energy Stone Analysis & Dual Energy Composition Analysis
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated, but described as "sample data sets from the predicate device verification activities (K131823)."
- Data Provenance: The data came from verification activities for the predicate device. Given the predicate is a Canon Aquilion system, it's likely institutional data, potentially multiple countries, but not specified as retrospective or prospective in this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The verification compared outputs to the predicate, implying the predicate's outputs were considered the "ground truth" or reference.
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Adjudication method: Not applicable/not described. The study was a direct comparison of outputs between the subject and predicate devices.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The study was a bench test verifying output similarity.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The "bench studies" compared outputs of the algorithm to the predicate's outputs, without explicitly mentioning human readers in a comparative evaluation. The "porting of this software" suggests the core algorithms are largely unchanged.
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The type of ground truth used: The "ground truth" for these applications appears to be the outputs of the predicate device (Aquilion Dual Energy System Package, K132813), which were used as a reference for comparison.
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The sample size for the training set: Not applicable/not stated. These applications are described as a "porting of application software," implying existing, validated algorithms rather than newly trained AI models requiring a training set in the typical sense.
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How the ground truth for the training set was established: Not applicable/not stated, as it's not a new AI algorithm requiring a training set described here.
Embolization Plan
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number, but refers to "sample data that was obtained from clinical institutions."
- Data Provenance: Obtained from "clinical institutions where local ethical controls were in place." This suggests real-world patient data, but whether it was retrospective or prospective is not specified. Country of origin not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: The data "was reviewed and verified independently by a test group and a control group." The size of these groups is not specified.
- Qualifications of Experts: Not explicitly stated, but implied to be "clinicians" capable of identifying "required feeder vessels for embolization planning."
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Adjudication method: Not explicitly described. The text mentions "reviewed and verified independently by a test group and a control group," which could imply some form of consensus or comparison, but details are absent.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not explicitly an MRMC comparative effectiveness study in the typical sense of comparing human readers with and without AI assistance. It refers to data being "reviewed and verified independently by a test group and a control group," which might be a form of clinical evaluation but isn't detailed enough to confirm an MRMC with effect size reporting.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The reported performance is about "assisting clinicians," implying a human-in-the-loop context.
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The type of ground truth used: The ground truth for the effectiveness of identifying feeder vessels would have been established by the "test group and a control group" of clinicians, based on their expert judgment and potentially clinical outcomes (though outcomes data is not stated). This points towards "expert consensus" or "expert judgment" as the basis for the ground truth.
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The sample size for the training set: Not applicable/not stated. This application is described as software that "assists physicians" and "provides tools to assist the user," implying a rule-based or conventional image processing approach rather than a machine learning model requiring a distinct training set.
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How the ground truth for the training set was established: Not applicable/not stated.
§ 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).