(84 days)
CardlQ Xpress 2.0 is intended to provide an optimized non-invasive application to andyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardlQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters 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 hyperdense 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 noncalcified 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 alian 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 informotion 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. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.
CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.
The provided text describes a 510(k) premarket notification submission for the GE Healthcare CardIQ Xpress 2.0 with SnapShot* Freeze Option. However, the document does not explicitly state acceptance criteria or the study details that prove the device meets specific performance criteria. It focuses on demonstrating substantial equivalence to a predicate device (CardIQ Xpress 2.0).
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in measurable terms (e.g., accuracy, sensitivity, specificity, or quantitative reduction in motion blurring) or reported device performance against such criteria. The submission aims to establish substantial equivalence to a predicate device, CardIQ Xpress 2.0. The "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections mention verification and validation activities, but they don't provide the results in a quantifiable way related to acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: The images used were "CT acquired clinical images... obtained from a non-significant risk reader study of care patient images." The country of origin is not specified, and it is a "reader study," implying retrospective use of existing patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- The text mentions a "non-significant risk reader study," which implies human readers were involved. However, it does not explicitly state that it was an MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance.
- Effect Size: No effect size or quantitative improvement of human readers with AI assistance is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The document implies that the device "aids in diagnosing" and "aids in determining treatment paths," suggesting it's an assistance tool for a human. It's not clear if a standalone performance study of the algorithm without human interaction was conducted and reported with specific metrics.
7. The Type of Ground Truth Used:
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcome data). Given it's a reader study, expert consensus is a likely, but unconfirmed, possibility.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not mentioned. The document describes verification and validation using "CT acquired clinical images" but does not distinguish between training and test sets or their respective sizes.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not mentioned.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on fundamental scientific technology and adherence to quality assurance measures. It lacks detailed quantitative performance metrics, specific acceptance criteria, and comprehensive information about the clinical study design, including sample sizes, expert qualifications, and ground truth establishment methods, which are typically found in more detailed study reports.
§ 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.