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CADstream is a computer aided detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and provides quantitative measurements of morphological features of the segmented tissues. CADstream performs other user-defined post-processing functions (image subtractions, multiplanar and oblique reformats, maximum intensity projections, image averaging, removal of cardiac artifact).

CADstream also can be used to provide accurate and reproducible measurements of the segmented tissues volumes (volumes of interest (VOI)). These measurements include longest diameter, longest in-plane diameters, volume measurement (reported in cc), ratio of breast volume to VOI, distance of VOI to anatomical landmarks, and 3D renderings of the VOI.

The system includes an optional remote image viewer (CADalyst™), optimized for viewing breast MR studies processed by CADstream. CADalyst also displays and telecommunicates images from a number of other medical modalities, including ultrasound and digitized mammographic images, processed data from FDA-cleared third party image processing systems, and FDA-approved systems for computer-aided detection and advanced image processing. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation.

CADstream™ includes software to support the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures (SureLoc™). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.

CADstream also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas.

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. CADstream is designed to analyze dynamic breast MRI studies.

The CADstream system consists of proprietary software developed by Confirma installed on off-the-shelf personal hardware. The CADstream System consists of the following key components:

• A PC Server: a desk-side or rack-mount PC capable of running the . Server software, Client User Interface software, and Study Viewer software
• Server software: performs CADstream analysis and processing .
• . Client User Interface software: an administrative web page hosted on the Server
• Study Viewer software (CADalyst): an Image Viewer component, . optimized for viewing breast MR studies processed by CADstream
• . Archive System: a PC with a combination CD/DVD burner and printer

To initiate CADstream analysis and processing, images are acquired and pushed to the CADstream system from the MR scanner. CADstream is configured to automatically process the images and create additional series. In this configuration, CADstream forwards the processed and original images to the existing softcopy reading station.

CADstream Version 4.0 includes the following software features:

• CADstream™, which allows the user to select a study to view, define . settings for CADstream processes, process and export CADstream results, and perform administrative tasks.
• CADalyst™ (the study viewer), which allows the user to view . CADstream results, interact with the volumes, curves, and AngioMap overlays, and print and save a CADstream Portfolio. This component can be accessed from a standalone CADstream workstation, a remote computer connected to the same network as the CADstream server, such as a PACS, or a PC.
• . CADalyst includes multi-modality viewing capabilities, allowing the user to view ultrasound and digitized mammographic images. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation.
• SureLoc™ is a guidance tool that assists the user in calculating target ● coordinates for biopsy, wire localization, or other interventional procedures.
• DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for CADstream query and retrieval.

The provided text is a 510(k) summary for the CADstream™ Version 4.0 device. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document outlines:

• Submitter and product identification
• Device description and features
• Indications for Use
• Comparison with predicate devices for substantial equivalence
• A letter from the FDA confirming substantial equivalence and allowing the device to be marketed.

Key regulatory aspects are discussed, but performance metrics, clinical study design, sample sizes, ground truth establishment, or expert involvement are not detailed. The document focuses on establishing substantial equivalence to existing devices for regulatory approval, rather than presenting a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present.

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