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The Volcano Angio-IVUS Mapping System is intended to provide a common frame of reference for intravascular ultrasound and angiographic images during diagnostic and/or interventional procedures for the coronary vasculature. The system provides indication of the location of the IVUS cross-sectional imaging plane for any given IVUS image as it relates to a two-dimensional (2D) angiographic image and/or the associated three-dimensional (3D) model formulated from multiple 2D image projections.

The Angio-IVUS Mapping System is an image acquisition and processing system on the In-Vision Gold Imaging console designed to process traditional X-ray angiographic images. A standard Ethernet cable links the In-Vision Gold Imaging System to the catheterization lab DICOM network, allowing the angiographic images to be transferred to the Angio-IVUS Mapping System. The system can be used to make a 3D reconstruction of a coronary subtree from two angiogram images taken at different angles. IVUS pullbacks acquired with the In-Vision Gold System can be mapped to the 3D reconstruction and the original 2D angiograms, resulting in a better tool for IVUS orientation and interpretation. In addition, Volcano's VH IVUS can (optionally) be performed, combining the detailed information of the arterial wall with the familiar angiographic roadmap.

The provided text is a 510(k) summary for the Volcano Angio-IVUS Mapping System, which describes the device and claims substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

Instead, the document states:

• Performance Data: "The information provided in the premarket notification demonstrates that the Angio-IVUS Mapping System is substantially equivalent to the predicate devices, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended use and fundamental scientific technology to a commercially available device."
• Conclusion: "The Volcano Angio-IVUS Mapping System has the same indication for use, and utilizes the same fundamental scientific technology as that of the predicate devices. The information provided in this premarket notification submission, along with the Declaration of Conformity to design controls supports a determination of substantial equivalence of the Volcano Angio-IVUS Mapping System to the predicate devices."

This indicates that the submission relies on comparison to predicate devices rather than a new performance study with explicit acceptance criteria for the new device's performance. Therefore, I cannot fill out the requested table or additional study details as that information is not present in the provided text.

The 510(k) process for this device type primarily focuses on demonstrating substantial equivalence in intended use and technological characteristics to a legally marketed predicate device, rather than requiring a detailed de novo clinical performance study against specific acceptance metrics for the new device.

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