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Volume Viewer Plus is a medical diagnostic software that allows the processing, review, and communication of 3D reconstructed images and their relationship acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

Volume Viewer Plus is a software package to be used on the GE Advantage Workstation, the GE Centricity PACS Workstation and the GE CT Operator Consoles (LightSpeed and HiSpeed). It allows the 3D processing, review and analysis of DICOM CT, MR, X-Ray Angio and PET images previously acquired, reconstructed and transferred on the corresponding workstation. This software provides Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MinIP, Average, Volume Rendering, Fly-Through) and their correlation to originally acquired images. Its user interface provides the tools to manipulate, annotate, measure and record these views as well as output an exam report. Additional features allow for segmentation of anatomy as well as display of multi-phase and/or fused hybrid images (PET/CT, PET/MR).

This 510(k) pertains to "Volume Viewer Plus," a software package for 3D processing, review, and analysis of medical images (CT, MR, X-Ray Angio, PET). The submission focuses on demonstrating substantial equivalence to previously cleared devices, rather than a de novo clinical study with specific acceptance criteria and performance data for a novel algorithm.

Therefore, many of the requested sections (acceptance criteria, performance, sample size for test/training, expert adjudication, MRMC study, standalone performance, ground truth details) are not applicable or not provided in this 510(k) summary. The summary focuses on comparing the new device's features and potential risks to its predicates.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission for a software upgrade/enhancement, not a de novo device with novel performance claims requiring specific thresholds. The "acceptance criteria" here is implicitly "performing as well as predicate devices" and "not introducing new safety risks."
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for Volume Viewer Plus itself. The claim is that it "performs as well as devices currently on the market" (i.e., the predicate devices).

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The submission does not detail a clinical test set for performance validation in the way a novel diagnostic device might.
• Data Provenance: Not specified. Given it's a software for existing imaging modalities, it would utilize DICOM images, but no specific dataset or its origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Reason: This information is typically required for studies demonstrating diagnostic accuracy. As this submission focuses on substantial equivalence of image processing/viewing software, such a clinical validation study with expert ground truth is not elaborated upon in the summary.

4. Adjudication method for the test set

• Not specified. (See explanation for point 3).

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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary.
• Reason: Volume Viewer Plus is described as software for 3D processing, review, and analysis of images, providing tools for clinicians. It is not an AI-assisted diagnostic algorithm intended to improve human reader performance in the typical sense that an AI CADe or CADx device would claim. Its enhancements are in visualization, segmentation, and workflow, which are intended to provide "clinically relevant information" but not explicitly quantified as a human reader performance uplift through an MRMC study in this document.

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

• Standalone Performance: No, a standalone algorithm performance evaluation is not mentioned.
• Reason: This device is a software package for clinicians to use, not an autonomous AI algorithm that performs diagnosis independently. It's an "accessory to Computed Tomography System" and "Magnetic Resonance diagnostic device."

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

• Not specified. (See explanation for point 3).

8. The sample size for the training set

• Not applicable/Not specified. This is a software package whose development would typically involve software engineering and validation against specifications, rather than machine learning model training on a "training set" in the context of AI.

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

• Not applicable/Not specified. (See explanation for point 8).

Summary of Device and Regulatory Context:

The Volume Viewer Plus submission is a 510(k) seeking clearance for a software product that provides enhanced 3D processing, review, and analysis capabilities for various medical imaging modalities. The core of the submission relies on demonstrating substantial equivalence to existing cleared devices (Advantage Windows Volume Rendering Option K972399 and CT Colonography / Navigator2 K012313). The justification for clearance is that the new features are enhancements to existing functionalities and do not introduce new safety risks, while performing as well as the predicates. The documentation focuses on software development and risk management processes rather than a clinical performance study with specific performance metrics and gold standards.

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