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Visia Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, manipulation, and printing of medical images. Visia Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

Visia™ Oncology is a noninvasive medical image processing software application intended for the visualization of images from various sources such as Computed Tomography systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Oncology integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. Visia™ Oncology is designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

The provided text indicates that "Visia™ Oncology" is a medical image processing software. However, the document does not contain specific acceptance criteria, a detailed study description, or performance metrics for the device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a specific study proving the device meets acceptance criteria, an MRMC study, standalone performance, or training/test set details based on this document.

Here's what can be extracted based on the information provided, assuming the "nonclinical testing" mentioned broadly refers to the evaluation of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." However, the specific acceptance criteria themselves (e.g., minimum accuracy for a particular task, specific tolerance for volumetric measurements, success rate for image registration) and the actual reported performance metrics against those criteria are not detailed in this 510(k) summary.

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

• Sample size for the test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "images from various sources such as Computed Tomography systems or from image archives."

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 beyond the general statement that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." There's no mention of specific experience levels or board certifications for anyone involved in establishing ground truth for testing.

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

• Not specified.

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 done: No, not mentioned in the document. The document describes the software as a tool to "support the physician" and provides "interactive tools," but it doesn't detail a study measuring improvement in human reader performance with or without the AI assistance.
• Effect size of improvement: Not applicable, as no MRMC study is detailed.

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

• The document implies the software is a standalone application but doesn't describe a standalone performance study of the algorithm itself in isolation from human interpretation. It emphasizes that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." So, if "standalone" refers to the algorithm making independent diagnoses or interpretations without human oversight, then no such study is described, as that is explicitly not its intended use.

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

• Not specified.

8. The sample size for the training set:

• Not specified. The document does not describe a machine learning training process or a training set.

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

• Not applicable, as no training set or machine learning model requiring ground truth for training is described. The device is characterized as "medical image processing software" that provides "viewing, quantification, manipulation, and printing." While it has "automated image registration" and "interactive tools specifically designed for segmentation and volumetric analysis," the underlying methods are not detailed as AI/ML that would require a distinct training phase.

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