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syngo TrueD is a medical diagnostic application for viewing, image manipulation, and fusion of medical images. syngo TrueD is intended for visualization and comparison of modalities and/or multiple time-points into a single dataset that accurately represents the information from the initial data. The input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic. This "fusion" of data may be viewed in a number of output formats including MIP and volume rendering.

syngo TrueD enables visualization of information that would otherwise have to be visually compared informally. syngo TrueD provides analytical tools to help the user visually assess, and document any morphological or functional activity at diagnostic examinations and therapy follow-up examinations. syngo TrueD is designed to support the user to confirm the absence or presence of oncological lesions. syngo TrueD is intended for the evaluation, quantification, follow-up and documentation of any such lesions.

Note: The clinician retains the ultimate responsibility for making the pertinent clinical decisions and practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.

syngo TrueD is image manipulation software that is intended to assemble existing datasets from imaging modalities into a single dataset that accurately represents the information from the initial data. This "fusion" of data from multiple modalities will be performed on 3D volume datasets and may be represented in a number of output formats including MIP and volume rendering. Additionally, simple quantitative measurements may be made and subsequently compared to a dataset acquired at a different point in time.

syngo TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers.

syngo TrueD supports DICOM formatted images and information. It is based on the Windows XP operating system.

The provided text from K041484 does not contain information about acceptance criteria, reported device performance metrics, or any studies with specific details about sample sizes, ground truth establishment, or expert involvement. The submission focuses on device description, intended use, technological characteristics, safety information, and substantial equivalence to predicate devices.

Therefore, I cannot populate the table or answer the questions regarding a study that proves the device meets acceptance criteria, as this information is not present in the provided document.

The document is a 510(k) summary and an FDA clearance letter for "syngo TrueD," a Picture Archiving and Communications System (21 CFR §892.2050). Its intended use is described as image manipulation software to assemble existing datasets from imaging modalities into a single dataset, perform "fusion" of 3D volume datasets, and represent them in various output formats including MIP and volume rendering. It also allows for simple quantitative measurements and comparisons. The document specifies that it supports DICOM formatted images and information, and is based on the Windows XP operating system. It states that the device has no patient contacting materials and is utilized only by trained professionals.

The basis for substantial equivalence is primarily through comparison to previously cleared predicate devices:

• syngo Multimodality Workstation (K010938)
• Lung CARE CT Software Package (K033374)
• Advantage Windows CT/PET Fusion (K010336)
• Leonardo Workstation (K040970, in review at the time)

The submission argues that "syngo TrueD does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device." This implies that the safety and effectiveness are established through equivalence, rather than through a direct performance study with acceptance criteria detailed in the submission.

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