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Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Myrian® with its modules is designed to run on standard PC hardware, through the installed operating system. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user. Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorised as follow: Enhanced imaging tools such as: Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MiniP, Average, Volume Rendering). Cross-sectional or Endoscope Exploration Modes along a centerline (e.g. of a vessel, a colon ... etc.). Filet Visualization Mode, to visualize as a flat surface any tubular hollow organ (such as a colon). Manual or interactive Objects Of Interest such as : Annotations of Interest, for information or measurement purposes. Paths (considered as Annotations of Interest). Regions of Interest, for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) through which any measurement can be performed. Points of Interest, for marking areas such as lesions, tumors ... etc. Reporting tools : Objects of Interest generates reports which may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or any other DICOM device. Manual or assisted image alignment tools : for multiphasic or time-based image comparisons. Cutting Surface Tool based on ROI for preoperative evaluation of surgery strategies (such as for the liver). All Myrian functionalities can be packaged, licensed and marketed as individual modules. The Myrian System allows the OEM customization of both the graphical user interface and the available functionalities, while implying no impact on the system performance or system intended use.

The provided text is a 510(k) Summary for the MYRIAN 1.4 image processing system. It describes the device's intended use and general operations but does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The document states:

• "Performance data were verified versus the requirements of the FDA 'Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices'"
• "User Site Testing and Benchmarking demonstrate that MYRIAN meet the required specifications. No adverse affects have been detected."

However, it does not provide any actual performance data, specific acceptance criteria, or details of the mentioned "User Site Testing and Benchmarking" study. Therefore, I cannot extract the requested information.

To answer your request, the input text would need to include a section detailing:

1. Specific numerical acceptance criteria (e.g., accuracy, precision, processing speed thresholds).
2. The measured performance of the device against those criteria.
3. Details about the study design, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, and whether it was a standalone or comparative effectiveness study.

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