(13 days)
CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.
CardIQ Fusion is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians in the evaluation and assessment of heart including its coronary vasculature and perfusion conditions.
CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.
The provided 510(k) summary for GE Healthcare's CardIQ Fusion device does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Description: Explaining what CardIQ Fusion is and its functionalities.
- Indications for Use: Defining the intended clinical applications.
- Comparison with Predicate Devices: Demonstrating substantial equivalence to existing cleared devices.
- Adverse Effects on Health: Stating that potential hazards are controlled through software development processes and adherence to standards.
- Conclusions: Reaffirming substantial equivalence and lack of new safety risks.
- FDA Clearance Letter: Official communication from the FDA confirming 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these are not present in the provided text.
Based on the nature of the 510(k) submission, particularly the reliance on substantial equivalence to predicate devices, it is common for such submissions to emphasize the similarity in performance and safety to already cleared devices rather than providing detailed, de novo performance studies with explicit acceptance criteria. The "study" mentioned in this context is likely the comparative analysis showing equivalence to the predicate devices.
§ 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.