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Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.

The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.

lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.

Key features:
General Viewing:

• · Linked 2D, MPR and 4D viewers for single and multi-study comparison
• · Creation of retrievable evidence and snapshots
• · User defined flexible display protocols

Access to Advanced Applications and Workflows:

• In application access to MR Stitching application
• · Evidence creation and sharing across workflows

General Image Display, Manipulation, and Analysis Tools:

• · Maximum and Minimum Intensity Projection (MIP/MinIP)
• · Identification and Display of Regions of Interest (ROIs)
• · CINE image display
• · Multi-frame display
• · Color image display
• . Simultaneous multiple studies review
• · Cross-reference lines support
• Display of selected images, series, or entire study .
• · Comparison of multiple series or studies
• · Scroll
• Pan
• Zoom
• · Focus
• · Flip (Vertically, horizontally)
• Invert
• · Rotate (Clockwise, counter-clockwise)
• · Arrow
• · Adjust Registration
• · Auto window level/width setting
• · Text/Arrow annotation (Label)
• · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI

Specialized Tools:

• · Image subtraction of two series/datasets
• · Access to semi-automated image stitching
• Study and series linking .
• · Register two different series or groups that do not share a frame of reference to link them spatially

The Multi Modality Viewer is a software application for examining and manipulating medical images from MRI and CT scanners.

It is considered substantially equivalent to its predicate device, the MR Core Software (K151115), which only handled MRI images, and a reference device, Softread Software (K040305), which supports both CT and MRI.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or a specific performance study comparison table for the Multi Modality Viewer beyond feature-by-feature comparison with predicate/reference devices. Instead, it focuses on demonstrating that the device has similar technological characteristics, intended use, and indications for use, and that verification and validation testing confirms its safety and effectiveness.

The document primarily performs a feature-by-feature comparison to establish substantial equivalence.

Overall Conclusion: The device is considered substantially equivalent because the added CT modality feature is similar to the reference device and does not raise different questions of safety and effectiveness. The verification and validation testing performed "demonstrate the subject device is as safe and effective as the predicate and reference devices."

2. Sample Size for Test Set and Data Provenance

The document mentions "Verification of the software that included performance and safety testing" and "Validation of the software that included simulated usability testing by experienced professionals." However, it does not specify the sample size used for any test set or the country of origin of the data, nor whether it was retrospective or prospective. The information provided is high-level about the testing processes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

For the "External Validation" mentioned under the "Validation" section, "experienced medical professionals evaluated the application." However, the exact number of experts and their specific qualifications (e.g., radiologist with 10 years of experience) are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set. It only states that "All validators confirmed that the Multi Modality Viewer software fulfills its intended use."

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study and therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. This device is a viewer, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study

The primary evaluation appears to be of the software's functionality as a viewer, not as an algorithm performing a specific diagnostic task in standalone mode. Verification and validation tests were conducted to confirm proper function of the device's features, but no standalone performance study measuring diagnostic accuracy or similar metrics for an algorithm without human-in-the-loop was reported.

7. Type of Ground Truth Used

The document indicates that "simulation usability testing by experienced professionals" and "workflow testing" were conducted, with "validators confirmed that the Multi Modality Viewer software fulfills its intended use." This suggests "expert consensus" on usability and fulfillment of intended use as the form of "ground truth" or validation outcome, rather than pathology, outcomes data, or a specific diagnostic ground truth, as the device is a viewing platform.

8. Sample Size for the Training Set

The document does not refer to a "training set" because the Multi Modality Viewer is described as a software application for viewing and manipulating images, not an AI/ML algorithm that requires a training set for model development.

9. How Ground Truth for Training Set Was Established

Since there is no mention of a training set, the method for establishing ground truth for a training set is not applicable or discussed.

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IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. Performs quantitative analysis of the left ventricle based on left ventricular angiograms. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings Assist in device positioning by providing real time localization on predefined roadmaps. Assists in projection selection using 3D modeling based on 2D images. Performs dimensional measurements based on DICOM images. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

The IC-PRO (version 3.5, model B) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. The IC-PRO provides quantitative data and vessel measurements, left ventricular, stent dimensions, enhances visualization, localizes device on predefined roadmaps and assist in projection selection. The IC-PRO is used in patient with vascular, congenital, valvular, and myopathic heart disease and patients undergoing vascular stenting and artificial valve deployment.

The provided documentation does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with statistical significance. It primarily consists of a 510(k) summary for the Paieon IC-PRO System, outlining its intended use, description, and claiming substantial equivalence to predicate devices.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance Data: Testing included software validation and performance evaluation. The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications."

However, the predetermined specifications (acceptance criteria) are not explicitly stated, nor are the specific accuracy and precision results reported in a quantifiable manner (e.g., specific percentages, ranges, or statistical measures).

Therefore, a table cannot be constructed with the information provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

The document discusses "software validation and performance evaluation" but does not mention a multi-reader multi-case (MRMC) comparative effectiveness study directly, nor does it provide any effect size for human reader improvement with or without AI assistance. The IC-PRO is described as assisting in diagnosis and analysis, implying human-in-the-loop, but no study is detailed to quantify its comparative effectiveness.

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

The document does not explicitly state whether a standalone performance study was conducted. Given the description of the system as providing "quantitative data and vessel measurements" and "enhances visualization," it implies that the output is intended to be used and interpreted by clinicians, suggesting a human-in-the-loop context. However, it's not definitively ruled out that some components might have been evaluated in a standalone manner without this detail being provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The document describes the system as "an image acquisition and processing modular software package," implying an algorithm, but details about its development and training are absent.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary of what is present:

• Device: Paieon IC-PRO System (version 3.5, model B), an image acquisition and processing modular software package for cardiovascular angiography.
• Intended Use: Assists in evaluating coronary lesions (3D imaging, quantitative dimensions), quantitative analysis of the left ventricle, enhancing stent deployment visualization, device positioning, projection selection, and dimensional measurements on DICOM images. Used in-procedure and off-line.
• Performance Data Mentioned: "Testing included software validation and performance evaluation. The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications."
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to several predicate devices (IC-PRO v3.2, Integris 3D-RA, Vitrea 2, iConnection PRO Stent Positioning System).
• Key Missing Information: All the detailed specifics requested about acceptance criteria, test set/training set sizes, data provenance, ground truth establishment, expert involvement, and study types (MRMC, standalone performance metrics) are absent from this 510(k) summary. This type of summary typically focuses on substantial equivalence rather than detailed study protocols and results.

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