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Innova Vision Applications software is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic irnages of the same anatomy in order to support catheter/device guidance during interventional procedures.

Innova Vision Applications image processing alaorithms are executed on a commercially available hardware platform called AW (Advantage Workstation), which can perform the followina functions:

• Superimpose the seamented DICOM 3D XA, CT, MR dataset on radioscopic or radioaraphic image of the same anatomy, obtained on an Innova Fluoroscopic Xrav svstem
• Register the segmented DICOM 3D XA, CT, MR data with radioscopic or radiographic images obtained on an Innova Fluoroscopic X-ray system for interventional procedures.
  The Innova Vision Applications software will be available as three different options (Innova Vision, TrackVision and EP Vision) that tarqet different clinical indications: catheter-based interventions for interventional procedures such as neuroradiology or interventional radiology; needle-based interventions for interventional radiology; and interventional cardiology procedures such as electro-physiology procedures, respectively.
  Each option contains specific functions and settings and supports 3D datasets from specific modalities.
  Innova EP Vision provides image stabilization features such as ECG gated display or motion tracking in the image.
  To enhance quidance capabilities, the Innova Vision Applications software can load planning data, deposited on the 3D model in Volume Viewer, such as 3D landmarks, ablations lines or traiectories for needle path, and display them on the 3D-2D fused image to support the physician during procedures. The application also allows marking points of interest such as ablation points during the procedures.
  To provide efficient workflow during the interventional procedures, the most frequently used functions can be controlled from tableside.

The provided 510(k) summary for the Innova Vision Applications states that no clinical studies were required to support substantial equivalence. Therefore, there are no acceptance criteria, device performance data, sample sizes, expert qualifications, or details about the ground truth from a clinical study to extract from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Not introducing new indications for use.
• Not raising new issues of safety and effectiveness.
• Not introducing new technology.

It also mentions compliance with voluntary standards (IEC60601-1-4 and IEC62304) and details quality assurance measures applied during development, such as risk management, requirements reviews, design reviews, and various levels of testing (unit, integration, system, and final acceptance testing/validation). However, these are internal development and compliance processes, not external clinical study results proving performance against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details as they are explicitly stated as not being part of this submission.

Here's a summary of what is stated regarding testing and evaluation, though it does not address the questions about acceptance criteria or specific study results:

• Summary of Non-Clinical Tests: The Innova Vision Applications Software complies with voluntary standards IEC60601-1-4 (2000) and IEC62304 (2006). Quality assurance measures included Risk Management, Requirements Reviews, Design Reviews, Software Unit Testing, Software Integration Testing, System Testing, and Final Acceptance Testing (Validation).
• Summary of Clinical Tests: "The subject of this premarket submission, Innova Vision Applications, did not require clinical studies to support substantial equivalence."

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