(110 days)
CardIQ Function Xpress is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.
CardIQ Function Xpress 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 Function Xpress 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 calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIQ Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.
Here's an analysis of the provided 510(k) summary regarding the GE CardIQ Function Xpress, focusing on acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for device performance (e.g., minimum accuracy, precision, or agreement with a reference standard). Instead, it states that "The results concluded the device was acceptable for use" after "Medical device design included testing and evaluation of previously acquired diagnostic images." This implies a qualitative assessment rather than a quantitative one, at least in the summary provided.
| Acceptance Criteria (Not explicitly stated with quantitative metrics in the document) | Reported Device Performance |
|---|---|
| Device functions as intended for analysis of cardiac parameters. | "The results concluded the device was acceptable for use." (Qualitative statement, no specific performance metrics provided in this document) |
| Software stability and reliability. | Software and medical device design validation have been completed. |
| Compliance with relevant standards. | Software designed to meet DICOM (PS 3.1 - 3.18) and AAMI/ANSI SW68 standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "testing and evaluation of previously acquired diagnostic images."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only states "previously acquired diagnostic images."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size
- MRMC Study: The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: The document describes the software as an "optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths" and to "automatically calculate and display various left ventricular and right ventricular functional parameters." While it implies the algorithm performs these actions, the provided summary does not contain details of a standalone performance study with specific metrics (e.g., accuracy, sensitivity, specificity of the algorithm's calculations compared to a reference). The statement "The results concluded the device was acceptable for use" is a general conclusion, not a detailed standalone performance report.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not specified. The document refers to "previously acquired diagnostic images," but does not explicitly state how the "true" values for cardiac parameters or disease presence were established for these images (e.g., expert consensus, pathology, follow-up outcomes data).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not mention a distinct "training set" or "training data" in the conventional sense of machine learning algorithm development. It refers to "medical device design included testing and evaluation of previously acquired diagnostic images," which could imply a testing phase, but no separate training phase is detailed. Given the date (2008), the development might have relied more on rule-based programming and traditional image processing rather than extensive machine learning requiring large, labeled training sets as is common today.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified, as a distinct training set is not explicitly mentioned or detailed in the summary.
In summary:
This 510(k) summary for CardIQ Function Xpress (K073153), cleared in 2008, is quite brief on the specifics of the performance study. It emphasizes design validation and compliance with general software and imaging standards rather than providing detailed quantitative performance metrics or extensive study design information typical of later AI/ML-driven device submissions. The "acceptance criteria" are implied as meeting the general usability and functionality requirements for a post-processing software option, concluding qualitatively that the "device was acceptable for use." Specific details on sample sizes, data provenance, expert qualifications, ground truth establishment, and comparative effectiveness studies are not present in this document.
§ 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.