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This device is indicated to acquire and display cross-sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.

The spectral imaging system utilizes two scan modes, spectral imaging scan and dual energy scan.

The spectral imaging scan allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.

The dual energy scan, utilized for brain imaging, allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube cotations. The X-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast may be gained from the differences in X-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials. Performance of dual energy scan may be affected by body size and motion artifacts.

When used by a qualified physician, a potential application is to determine the course of treatment

PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac applications.

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 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.

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

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 eleven post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Spectral Stone Analysis, Spectral Composition Analysis, Embolization Planning Tool and Spectral Analysis 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 summary of the acceptance criteria and study information for the Vitrea Software Package, VSTP-001A, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for Vitrea Software Package, VSTP-001A

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for improved performance. The "acceptance criteria" can be inferred from the studies conducted to show that the new/modified features (specifically related to Spectral Analysis and additional display options) meet specifications and perform as intended, or offer equivalent/improved performance compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a "test set" in the context of clinical images for the Vitrea Software Package. The performance testing mentioned primarily involved:

• Bench testing: This would involve laboratory-based tests on the software without human data.
• Phantom studies: These use artificial objects (phantoms) instead of human subjects.
• Clinical Images (for Aquilion ONE): For the associated CT scanner (Aquilion ONE), "Representative body, cardiac, low dose chest and head diagnostic images, reviewed by an American Board Certified Radiologist" were obtained. However, this refers to the acquisition capabilities of the CT scanner, not directly to the evaluation of the Vitrea Software Package's specific new features.

Therefore, for the Vitrea Software Package, there is no stated sample size for a clinical test set directly evaluating the software's new features. The primary evaluation focused on technical performance using phantoms.

Data Provenance: Not explicitly stated for specific test sets related to the Vitrea software. The studies mentioned are primarily technical (bench and phantom studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• For the Vitrea Software Package: The document does not specify the use of experts to establish ground truth for a test set directly related to the new software features. Evaluation appears to be based on technical specifications and phantom studies.
• For the Aquilion ONE (CT Scanner) clinical images: "An American Board Certified Radiologist" reviewed images for diagnostic quality. This indicates at least one expert was used, but the purpose was general diagnostic quality rather than establishing ground truth for specific algorithm performance metrics.

4. Adjudication Method for the Test Set

Not applicable, as no external expert-adjudicated test set is described for the Vitrea Software Package's new features.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described for the Vitrea Software Package. The document focuses on demonstrating substantial equivalence based on technical performance and phantom studies, and the new features are primarily tools for visualization and analysis, not AI assistance for human readers in a diagnostic setting that would typically require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The performance testing primarily involved standalone algorithm components evaluated through bench testing and phantom studies. For example, the Spectral Analysis application's ability to generate monochromatic images, iodine maps, electron density images, etc., and the functionality of new display modes, would have been evaluated primarily in a standalone manner against technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Vitrea Software Package:

• Technical specifications/expected outputs: The "ground truth" for the new features was primarily based on predefined technical specifications and expected outputs from phantom studies (e.g., accurate generation of monochromatic images, proper functioning of display modes).
• Phantom studies: Phantoms are designed with known properties, serving as a form of "ground truth" for evaluating image quality metrics.

No mention of expert consensus, pathology, or outcomes data being used as ground truth for the Vitrea Software Package's new features.

8. The Sample Size for the Training Set

Not applicable. The document describes a "Software Package" with modifications to existing features, not a deep learning algorithm that requires a "training set." While the Aquilion ONE CT scanner mentions AI-based reconstruction (AiCE, PIQE), the FDA submission for the Vitrea Software Package itself does not describe a training set for the software's functional updates.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for the Vitrea Software Package in this submission.

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