Search Results

CAAS Workstation is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading, co-registering and interpreting cardiovascular X-Ray images to support diagnoses and for assistance during intervention of cardiovascular conditions.

CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:

• Calculate the dimensions of cardiovascular structures;
• Quantify stenosis in coronary and peripheral vessels;
• Quantify the motion of the left and right ventricular wall;
• Perform density measurements;
• Determine C-arm position for optimal imaging of cardiovascular structures;
• Enhance stent visualization and measure stent dimensions;
• Co-registration of angiographic X-Ray images with IVUS and OCT images.

CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS Workstation are used in a clinical setting to support diagnoses and for assistance during intervention of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS Workstation is designed as a stand-alone modular software product for viewing and quantification of X-ray angiographic images intended to run on a PC with a Windows operating system. CAAS Workstation contains the analysis modules QCA, QCA3D, QVA, LVA, RVA and StentEnhancer of the previously cleared predicate device CAAS Workstation (K133993) for calculating dimensions of coronary and peripheral vessels and the left and right ventricles, quantification of stenosis, performing density measurements, determination of optimal C-arm position for imaging of vessel segments and functionality to enhance the visualization of a stent and to measure stent dimension. Semi-automatic contour detection forms the basis for the analyses.

Functionality to co-register X-ray angiographic images and intravascular imaging techniques (such as intravascular ultrasound and optical coherence tomography) is added by means of the analysis module IV-LINQ. With co-registration a common frame of intravascular imaging techniques with X-ray angiographic images is provided using a three-dimensional model. This functionality is based on the Volcano Angio-IVUS Mapping system (K060483).

In the IV LINQ workflow the user has to select two angiographic X-ray images in DICOM format. The user indicates a catheter path starting at the imaging tip. This path can be optimized manually by adding, deleting or moving control point on the drawn path. After the catheter path is drawn in both angiographic X-ray images, a 3D reconstruction of the catheter path is calculated.

The user then has to select one IVUS or OCT dataset in DICOM format or the data is streamed from the intravascular imaging console with a DVI streamer. The IVUS or OCT pullback must be acquired using a motorized pullback device. After the 3D catheter path from X-ray angiographic images is calculated and the IVUS or OCT pullback is loaded, IV-LINQ co-registers each IVUS or OCT frame with a position on the 3D catheter path using a distance mapping algorithm. On intravascular images diameter and area measurements can be performed.

The quantitative results of CAAS Workstation support diagnosis and intervention of cardiovascular conditions. The analysis results are available on screen, and can be exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

The provided text describes the CAAS Workstation and its regulatory submission. It mentions performance data and validation efforts but does not provide explicit acceptance criteria in a table format, nor does it detail a specific study with quantitative results proving adherence to such criteria.

However, I can extract the information provided regarding the device's validation and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics. Instead, it offers a general statement about performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective) for training or testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications for any part of the testing.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method used for a test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study being done, nor does it provide any effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study:

The document implies a standalone performance for the algorithm through statements like "System testing showed that the system requirements were implemented correctly" and "proper functioning of the algorithms is validated." However, it does not explicitly detail a dedicated standalone study with specific metrics. The focus is on the software's functionality and accuracy of its calculations.

7. Type of Ground Truth Used:

The document describes "validation approaches" and "proper functioning of the algorithms," and "accuracy and reproducibility requirements" for length measurements. This suggests the ground truth was likely established through:

• Reference measurements or calculations for quantitative aspects (e.g., vessel dimensions, stenosis quantification).
• Comparison to accepted standards or methods for qualitative aspects or algorithmic outputs.

However, the document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set.

9. How Ground Truth for the Training Set Was Established:

As no training set size is provided, the document does not explain how ground truth for a training set was established.

Ask a specific question about this device