(87 days)
CAAS QxA 3D is used for:
- 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray images;
- Calculation of dimensions of the vessel corrected for out-of-plane magnification and foreshortening errors;
- To determine acquisition parameters for optimal imaging of part of interest on a vessel tree;
- To assist in the positioning of implantable devices in the vessel segment of interest.
The CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist.
Indications for use: CAAS QCA 3D: coronary arteries CAAS QVA 3D: peripheral vessels
The CAAS QxA 3D covers the QCA 3D and QVA 3D software modules intended to run on the Cardiovascular Angiography Analysis System (CAAS). The CAAS QxA-3D is designed for objective, accurate and reproducible assessment of the vessel geometry from a set of angiographic X-ray images from different projections. The variant QCA 3D is intended for coronaries and the variant QVA 3D is intended for peripheral vessels.
On each of the 2D images an arterial segment is selected resulting in automatic contour detection. The detected 2D arterial contours in each image are used to generate a 3D reconstruction of the arterial segment. A number of analysis results can be calculated.
- Vessel dimensions such as area, diameter and length;
- Reconstruction of healthy vessel shape;
- User defined subsegments analysis.
Results are corrected for out-of-plane magnification and foreshortening errors. CAAS QxA 3D features a virtual display of an implantable device on the 2D images and assists to plan its position based on the 3D reconstruction.
The provided text does not contain information about specific acceptance criteria, study design details, or performance metrics from a study to prove the device meets acceptance criteria.
The 510(k) summary (K100292) for the CAAS QxA 3D device primarily focuses on:
- Device Description and Intended Use: Explaining what the device does (3D reconstruction, vessel dimension calculation, planning for implantable devices) and who uses it (cardiologists or radiologists).
- Substantial Equivalence: Stating that the device is substantially equivalent to predicate devices (CAAS, CAAS QCA 3D, IC-Pro) based on its intended use and technological characteristics.
- Performance Data: A single, vague statement: "CAAS QxA 3D is developed, tested, validated and produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging."
There is no mention of:
- Specific acceptance criteria (e.g., minimum accuracy percentages, error margins).
- A study demonstrating the device's performance against such criteria.
- Sample sizes for test sets or training sets.
- Data provenance, ground truth establishment methods, or expert qualifications.
- Comparative effectiveness studies (MRMC), standalone performance, or human-in-the-loop performance.
Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided document. The document confirms that the FDA concluded the device is "safe and effective for its intended use" based on the substantial equivalence argument and the company's QA system, but it does not detail the underlying performance data or studies that would typically be used to demonstrate meeting acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).