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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).

1. 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. |

2. 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.

3. Number of Experts and Qualifications: Not specified for this particular application.

4. Adjudication Method: Not specified.

5. MRMC Comparative Effectiveness Study: No, the text describes bench testing comparing outputs, not a human reader study.

6. Standalone Performance: Yes, the described "bench testing" compared the outputs of the subject and predicate devices, which implies standalone algorithmic performance.

7. 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.

8. Training Set Sample Size: Not specified.

9. 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).

1. 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. |

2. 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.

3. Number of Experts and Qualifications: Not specified for this particular application.

4. 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.

5. 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."

6. 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.

7. 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.

8. Training Set Sample Size: Not specified.

9. Ground Truth for Training Set: Not specified.

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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.

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

1. 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.

2. 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.

3. Adjudication method: Not applicable/not described. The study was a direct comparison of outputs between the subject and predicate devices.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The study was a bench test verifying output similarity.

5. 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.

6. 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.

7. 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.

8. 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

1. 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.

2. 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."

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established: Not applicable/not stated.

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