(111 days)
CardIQ Xpress 2.0 is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
CardIQ Xpress 2.0 is a CT, non-invasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional and mothers of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0 the user can color code the myocardial tissue to show hypo/hyper-dense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to align the heart. The IVUS-like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added.
CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
The GE Medical Systems CardIQ Xpress 2.0 software is a post processing software option for the Advantage Workstation (AW) Platform, CT scanner, PACS or Centricity systems. This product can be used in the analysis of CT angiographic images to view the coronary vessels to determine if the patient has normal coronary arteries, arteriolosclerosis or severe stenosis, which needs to go on for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIQ Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.
The provided document does not contain acceptance criteria or detailed study results that would allow for the construction of the requested table and comprehensive answers to all questions. The document is a 510(k) summary for the GE Medical Systems CardIQ Xpress 2.0 software, which primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific measurements like reduction in read time or improved diagnostic accuracy).
Instead, it broadly states:
"The results concluded the device was acceptable for use."
This general statement is the only "reported device performance" available in this document. It implies that internal validation, including software and medical device design validation, found the device suitable for its intended purpose without providing specific metrics against which performance was assessed.
Missing Information and Limitations of the Provided Document
Due to the nature of this 510(k) summary, specific details regarding the validation study are largely absent. Therefore, many of the requested points cannot be answered from the provided text.
Here's a breakdown of what cannot be answered:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. While the device aids in diagnosis and workflow, no MRMC study or quantitative improvement metrics are presented.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned. The device is described as a "post processing software option" and "image analysis software package, which aids in diagnosing," implying a human-in-the-loop system. Standalone performance is not detailed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. "Evaluation of previously acquired diagnostic images" is vague regarding how ground truth was established for these images. "Testing on phantoms" is also mentioned, referring to physical models, not clinical ground truth.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned, as training set details are absent.
Summary of Non-Clinical and/or Clinical Tests and Results (as provided)
The document refers to a "Summary of non-clinical and/or clinical tests and results" section, which only states:
- Standards:
- PS 3.1 - 3.18 (NEMA) - Digital Imaging and Communications in Medicine (DICOM)
- SW68 (AAMI/ANSI) - Medical Device Software - Software life cycle processes
- Validation: "The software was designed to meet the following standards: Software and medical device design validation have been completed. Medical device design included testing on phantoms and evaluation of previously acquired diagnostic images."
- Conclusion: "The results concluded the device was acceptable for use."
This indicates that general software development and medical device design standards were followed, and some level of testing was performed using phantoms and existing diagnostic images. However, the specific results of these tests that would demonstrate "acceptance criteria" against "reported device performance" are not disclosed in this 510(k) summary.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.