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syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality post-processing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.

The syngo.via MI Workflows software addresses the needs of the following typical users of the product:

• Reading Physician / Radiologist – Reading physicians are doctors who are trained in interpreting patient scans from PET, SPECT and other modality scanners. They are highly detail oriented and analyze the acquired images for abnormalities, enabling ordering physicians to accurately diagnose and treat scanned patients. Reading physicians serve as a liaison between the ordering physician and the technologists, working closely with both.
• Technologist – Nuclear medicine technologists operate nuclear medicine scanners such as PET and SPECT to produce images of specific areas and states of a patient's anatomy by administering radiopharmaceuticals to patients orally or via injection. In addition to administering the scan, the technologist must properly select the scan protocol, keep the patient calm and relaxed, monitor the patient's physical health during the protocol and evaluate the quality of the images. Technologists work very closely with physicians, providing them with quality-checked scan images.

The software has been designed to integrate the clinical workflow for the above users into a server-based system that is consistent in design and look with the base syngo.via platform and other syngo.via software applications. This ensures a similar look and feel for radiologists that may review multiple types of studies from imaging modalities other than Molecular Imaging, such as MR.

The syngo.via MI workflows software supports integration through DICOM transfers of positron emission tomography (PET) or nuclear medicine (NM) data, as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

Although data is automatically imported into the server based on predefined configurations through the hospital IT system, data can also be manually imported from external media, including CD, external mass storage devices, etc.

The Siemens syngo.via platform and the applications that reside on it, including syngo.via MI Workflows, are distributed via electronic medium. The Instructions for Use is also delivered via electronic medium.

syngo.via MI Workflows includes 2 workflows (syngo.MM Oncology and syngo.MI General) as well as the Scenium neurology software application and the syngo MBF cardiology software application which are launched from the OpenApps framework within the MI General workflow.

Here's a breakdown of the acceptance criteria and study details for the syngo.via MI Workflows, Scenium, and syngo MBF devices:

Acceptance Criteria and Reported Device Performance

For Lung and Lung Lobe Segmentation:

For PERCIST Liver Reference Region Placement (Binary Liver Mask, input to the algorithm):

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MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, cardiology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.

MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners. MI View&GO software provides additional specific capabilities for handling of PET and SPECT as well as CT and MR data directly at the acquisition console.

The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to:

• Review acquired and reconstructed images at the scanner console
• Determine that the acquired data is of sufficient quality for reading, so the patient can be released.
• Prepare images for reading
• Perform a basic read

The provided text is a 510(k) summary for the device MI View&GO VA30. It states that "The device under application, MI View&GO, did not conduct any additional performance testing" for determining substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria as described in the prompt was not conducted and thus, the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) is not available in the provided text.

The substantial equivalence determination was based on:

1. Software Verification and Validation: This involved demonstrating continued conformance with special controls for medical devices containing software. The testing supported that all software specifications met predetermined acceptance criteria and substantiated all requirements and functional specifications, including those related to device hazards.
2. Risk Analysis: A risk analysis was completed, and risk control was implemented to mitigate identified hazards.
3. Comparison to Predicate Device: The device was deemed substantially equivalent to the predicate device (MI View&GO VA20, K201202) because there are no differences in the Indications for Use, Intended Use, or Fundamental Technological Characteristics. The new features implemented (e.g., O Brain AC-PC, PERCIST, VOI Isocontour) did not raise any new issues of safety and effectiveness.

In summary, the document indicates that the device's performance was not evaluated through a specific comparative study against acceptance criteria of the kind typically seen for novel diagnostic algorithms. Instead, its substantial equivalence was primarily established through software verification and validation, risk analysis, and a direct comparison of its technological characteristics and intended use to a previously cleared predicate device.

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