(14 days)
Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
AVA II automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure area's of abnormalities within a vessel.
CT Advanced vessel analysis (AVA II / AVA 2) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.
Advanced vessel analysis is a software post-processing package for the Advantage Workstation (AW) platform, CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, thrombus, pre/post stent planning procedures and directional vessel tortuosity visualization.
This 510(k) submission for the GE Healthcare Advanced Vessel Analysis II (AVA II) does not contain a detailed study with acceptance criteria and device performance results in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and general safety considerations.
Here's a breakdown of the available information and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not provided. The submission states that the device "performs as well as devices currently on the market" and that potential hazards are controlled by "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." However, specific acceptance criteria for performance metrics (e.g., accuracy in stenosis measurement, plaque analysis) and the quantitative results validating these are not included in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. There is no mention of a specific test set, its size, or the provenance of any data used for validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. Since no specific test set or ground truth establishment process is described, this information is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
5. 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 provided. The document does not describe any MRMC study or any results quantifying human reader improvement with AVA II. The device is described as a "post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians," implying a human-in-the-loop system, but no comparative effectiveness study is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. The device is described as an "application to analyze vascular anatomy and pathology and aid in determining treatment paths," suggesting it's intended to assist human interpretation rather than act as a standalone diagnostic tool. No standalone performance results are discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided.
8. The sample size for the training set
- Not provided. This submission does not include information on a training set as would be relevant for a machine learning or AI-driven device undergoing typical validation studies. The AVA II is described more as a "post processing analysis software package" with "automatic visualization tools," suggesting it might be based on established image processing algorithms rather than a learning-based model in the modern AI sense.
9. How the ground truth for the training set was established
- Not provided.
Summary of what is available:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to previously cleared devices (Smart Vessel Analysis, CardIQ Analysis III, Auto Bone). The mechanism for ensuring safety and effectiveness is stated as adherence to:
- Software Development, Validation, and Verification Processes
- Federal Regulations
- User Requirements
- Industry and International Standards
Without the full details of these validation processes, specific performance metrics against defined acceptance criteria cannot be extracted from this summary. The submission indicates that a risk management summary (hazard analysis) was performed, and the controls mentioned above address those risks. However, quantitative performance data is not made public in this summary 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.