Search Results

Vitrea is 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 is not meant for primary image interpretation in mammography.

The Vitrea Advanced Visualization software is 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.

The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

• Retrieve image data over the network via DICOM
• Display of images in dedicated protocols which are automatically adapted based on exam type
• Select images for closer examination from a gallery of 2D or 3D views
• Interactively manipulate an image in real-time to visualize anatomy and pathology
• Annotate, measure, and record selected views
• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
• Retrieve reports that are archived on a Web server

The provided document is a 510(k) summary for Vitrea Advanced Visualization, Version 7.6. This documentation focuses on demonstrating substantial equivalence to a predicate device (Vitrea, Version 7.0 (K150258)) by detailing software changes, intended use, and technological similarities.

Crucially, this document does not describe acceptance criteria for device performance based on clinical outcomes or a study that specifically proves the device meets such criteria. Instead, it discusses:

• Software Verification Testing: This ensures that new features operate according to defined requirements (functional and performance specifications internal to the company for the software itself).
• Risk Management: Assessment of potential harms associated with software modifications and implementation of controls to reduce these risks.
• Compliance with Standards: Adherence to recognized consensus standards like DICOM, ISO 14971, and IEC 62304.

The document explicitly states: "The subject of this 510(k) notification, Vitrea Advanced Visualization software, did not require clinical studies to support safety and effectiveness of the software." This indicates that there are no clinical acceptance criteria or studies providing device performance metrics in the way you've outlined.

Given this, I cannot provide details on your specific requests for acceptance criteria, device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, or training set ground truth. These are typically associated with clinical performance studies, which were not conducted or required for this 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the software's functional and technical requirements and the verification testing performed to confirm these requirements are met.

Below is a table summarizing the information that is available regarding the device's assessment, which relates to software functionality and risk, rather than clinical performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and performance reported here are for software functionality and safety features, not clinical diagnostic performance, as clinical studies were not required or performed for this 510(k) submission.

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

Not applicable for clinical performance. For software verification, the "test set" and "data provenance" would refer to the specific test cases and data used for software testing, which are internal to the manufacturer and not detailed in this 510(k) summary.

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

Not applicable, as no clinical test set for diagnostic performance was used.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance was used.

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

Not applicable. The document explicitly states no clinical studies were performed. This device is described as "Radiological Image Processing Software" and not an AI-assisted diagnostic tool that would typically undergo such studies.

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

Not applicable, as this is software for processing and visualization, not a standalone diagnostic algorithm requiring performance evaluation. No clinical studies were done.

7. The type of ground truth used

Not applicable, as no clinical outcome-based ground truth was established. For software verification, "ground truth" implies the expected output or behavior according to the software requirements.

8. The sample size for the training set

Not applicable, as no clinical studies or machine learning model training are described in this 510(k) summary.

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

Not applicable, as no training set for a machine learning model is mentioned or elaborated upon.

Ask a specific question about this device