Search Results

The VersaVue™ Enterprise Suite consists of the MR Analysis Server software and the VersaVue Enterprise Workstation software.

The MR Analysis Server software, which includes the SpectraLook®, VividLook® and OmniLook modules is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.

The VersaVue Enterprise Workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the Suite's underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

The VersaVue Enterprise Suite is intended for post-processing of MR datasets to provide a reliable means for visualizing MR datasets and supports the evaluation of dynamic and non-dynamic MRI datasets. It is also designed to provide study review and mathematical. and/or statistical analysis. The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis.

The VersaVue Enterprise Suite consists of the following two products; each product in turn incorporates individual modules:

1. MR Analysis Server Software_consists of:

• SpectraLook, for Breast MR analysis .
• VividLook, for Prostate MR analysis .
• OmniLook, for analysis of other MR datasets .
• 2. VersaVue Enterprise Workstation Software
  • PrecisionPoint, for MR Breast Interventional Planning (K090223) o

The MR Analysis Server Software is intended to be used as a post-processing software package designed to provide a reliable means for visualizing MR data. The data analysis supports the evaluation of dynamic and non-dynamic MR datasets. The MR Analysis Server software also analyzes contrast enhanced magnetic resonance imaging (DCE-MRI) studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained. physician the information provided by the software yields information that may assist in the interpretation of dynamic contrast enhanced studies.

The VersaVue Enterprise Workstation Software is intended for use in conjunction with SpectraLook, VividLook and OmniLook MR post-processing analysis software to provide study review and additional mathematical and/or statistical analysis. The Workstation software does not change the SpectraLook, VividLook or OmniLook software algorithm or the image series produced by the algorithm. It supports the analysis and presentation of the original MR datasets and the results generated by the software algorithm and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

The Workstation software also works with iCAD's PrecisionPoint Breast Interventional biopsy software. The Breast Interventional Planning Software cleared under K090223 integrates intervention planning ability into the existing iCAD viewing workstation, allowing physicians to read images followed by subsequent planning of MRI-guided percutaneous breast biopsies and other interventional procedures. Biopsy planning, puidance and all necessary documentation are generated through the same Workstation interface.

The provided text describes modifications to an existing device, the VersaVue Enterprise Suite, and claims substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) Summary for a Special 510(k) Device Modification. This type of submission typically focuses on demonstrating that changes to an already cleared device do not alter its fundamental scientific technology, intended use, or safety and effectiveness, by showing equivalence to previously cleared predicates or the modified version of the same device. It does not generally include detailed performance studies with acceptance criteria as would be found in a de novo or traditional 510(k) submission for a novel device or significant change.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

The text does state:

• "Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirement were met. Test data was used that met the requirements to validate system performance." (Page 4, Section 6.7)

This generally indicates that internal testing was conducted to ensure the software functions as designed and that changes introduced by the modification did not negatively impact its operation. However, no specific metrics, acceptance criteria, or study details are provided.

Ask a specific question about this device