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iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, and Clinical Specialists with the visualization and measurements of the heart and vessels.

iNtuition-Structural Heart Module enables the user to:

• · Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and for post-operative evaluation.
• · Quantify calcium (volume, density)

iNtuition-Structural Heart Module has the following tools and features that facilitate:

• · Automatic and manual centerline detection.
• · Segmentation of cardiovascular structures.
• · Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions of vessels and structures.
• · Calcium quantification and scoring.
• · Various visualization techniques: 2D/3D/4D visualization, MPR, Stretched MPR, MIP, MinlP, Raysum and MAR.
• · Capture and Report.

iNtuition-Structural Heart Module is an optional image post-processing software module using iNtuition (K121916) standard features and part of its optional features. It is a software device generally used with the off-the-shelf hardware, offered in various configurations, with the simplest configuration being a stand-alone workstation capable of image review, communications, archiving, database maintenance, remote review, reporting and basic 3D capabilities. It can also be configured as a server with some, or with all, or none of its optional features.

Whether provided as a workstation or a server, the iNtuition-Structural Heart Module software is designed to provide access by a local user physically sitting at the computer hosting the iNtuition server software, and/or by one or more remote users who concurrently connect to the server using a freely-downloadable thin client application or through a zero-footprint web viewer (with conference capabilities) over local network or internet.

iNtuition-Structural Heart Module is iNtuition (K121916) based optional feature and employs all standard features offered by iNtuition such as convenient image manipulation tools like drawing of region of interests, manual and automatic segmentation of structures, image assessment and measurement tools - linear, diameter, angle, area and volume and tools that support the creation of reports, transmitting and storing this report in digital form and tracking historical information about the studies analyzed by the software. iNtuition Vessel analysis and calcium scoring features are utilized to support automatic and manual centerline extraction and analysis and calcium quantification.

iNtuition-Structural Heart Module:

• . Supports the visualization and quantification of coronary vessels and cardiac structures for anatomic and pre- or post-operative evaluations through guided clinical workflows.
• . Enables the assessment and measurement of different structures of the heart, e.g. aorta, aortic valves, mitral valve, pulmonic valve, atria and atrial appendages, and ventricles.
• . Provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures via 3D measurements.
• Uses the same iNtuition (K121916) Vessel Analysis and Calcium modules.Enables .
  assessment and measurement of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.Supports the creation, transmission and storage of a report in digital form. It can also track historical information about the studies analyzed by the software.Displays results analysis, that can be printed as hardcopy or saved in a variety of formats to a hard disk, network, PACS system or CD/DVD/USB.

The provided text is a 510(k) Premarket Notification submission for the TeraRecon iNtuition-Structural Heart Module. It is a regulatory document declaring substantial equivalence to predicate devices, rather than a detailed study report proving the device meets specific acceptance criteria based on performance metrics.

The document explicitly states: "iNtuition-Structural Heart Module did not require clinical studies to demonstrate its safety and effectiveness." This means that the information you've requested regarding performance data, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for demonstrating the device meets acceptance criteria via a pre-defined study is not present in this regulatory filing.

Therefore, I cannot extract structured information about specific acceptance criteria and a study proving the device meets them from this document. The FDA clearance is based on a claim of substantial equivalence to existing predicate devices, meaning it has similar indications for use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.

The "Performance Data" section (Page 10) only mentions:

• "The verification and Validation tests have been performed to address the indication for use, the technological characteristics claims, requirement specifications and risk management results."
• "Software testing and validation were done according to written test protocols established before testing was conducted."
• "Test results were reviewed by designated technical professionals before being formalized and after ensuring that the software fully satisfies all expected and previously defined system requirements and features. Test results support the conclusion that iNtuition- Structural Heart Module performance satisfies the design intent and is equivalent to its predicate devices."

This describes internal software verification and validation activities, which are typically for functional correctness and adherence to design specifications, not a comparative clinical performance study against specific, quantified acceptance criteria for diagnostic accuracy or clinical outcomes that would usually involve human readers or external ground truth.

In summary, the document states that a clinical performance study was not required. Thus, I cannot provide the details you requested in the structured format, as the information is not available in the provided text.

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