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The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data.

The Voxar 3D product family provides several levels of functionality:

• Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved MPRs, slab MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
• Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vescular and other tubular structures, boundary detection, and PET image analysis.
• Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Also included are computer-sided detection signithms which are the user on possible structures of interest. Specialized dinical applications include:
  • Colon Screening (which Is intended for the screening of patients for colonic polyps, turnours and other o lesions using tomographic Colonography),
  • Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o anglographic studies to evaluate occusive and aneurismal diseases and the effectiveness of stents and stent grafts)
  • Coronary analysis (which is Intended for the qualitative and quantitative analysis of coronary 0 arteries to evaluate occlusive and aneurismal disease).
  • Functional cardiac analysis (which is intended to evaluate the functional characteristics of the heart),

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The provided text is a 510(k) premarket notification acceptance letter for the "Voxar 3D Enterprise with CardiaMetrix" device. It does not present a study with acceptance criteria and device performance results. This document summarizes that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot extract the information required for your request from this document. The information you are asking for, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study details, would typically be found in a separate study report or a more detailed section of the 510(k) submission, not in the FDA's acceptance letter itself.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... " This indicates that the device's acceptability was based on its similarity to existing devices, rather than on a new clinical study demonstrating specific performance metrics against defined acceptance criteria within this document.

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