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The COHERENCE Dosimetrist Workspace v2.2 is a comprehensive oncology workflow software package that allows for both CT simulation as well as inverse radiation therapy treatment planning and optimization in one software package to aid in oncology clinical workflow. This workspace is comprised of two major components, the CT Simulation component (VSIM) and the inverse radiation therapy treatment planning component (KonRad).

The VSIM component permits CT simulation to be performed on the syngo workstation. The CT scans are first loaded into the VSIM software component and the user is able to create three-dimensional models of targets and organs. The user is able to identify the patient isocenter, place treatment beams, and identify beam modifiers (blocks, apertures, and MLCs). The information is then available for radiation treatment planning for dose calculation via the KonRad software component or other treatment planning systems. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.

The KonRad software component is intended to optimize multi-leaf (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, linear accelerator, or record and verify system, for final verification prior to treatment delivery. The KonRad software component allows for efficient inverse radiation therapy treatment planning and optimization.

The COHERENCE Dosimetrist Workspace v2.2 integrates the functionality of two previously released Siemens Medical Solutions USA, Inc. products (VSIM and KonRad, Model v2.0) with the addition of further enhancements to this pre-existing functionality. The integration allows for the sharing of data with all other application components within the COHERENCE Dosimetrist Workspace v2.2. This new software package is based on the syngo user interface standard which was cleared via K010938.

The existing functionality (as previously cleared by VSIM (K022036) and KonRad (K022307)) is described by the following components:

VSIM component: The VSIM component is intended to give the user general viewing and examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSIM part of this component and it is possible to load other modality images, in conjunction with the CT images for treatment planning. The VSIM component is intended to provide tools for delineating and representing targets and critical structures. The component enables the user to design complex beam profiles and place them for optimum radiation therapy treatment. A three dimensional graphical representation allows for a virtual setup and treatment of the patient without involving the patient.

KonRad component: The KonRad component is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). The KonRad component uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via DICOM RT protocols from various sources such as CT. The site-specific treatment machine beam data is utilized for plan calculation. The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimization calculations according to the importance of reaching the dose objectives for the target and other structures. The KonRad component will calculate the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This process is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. The input parameters can be modified and the optimization repeated until the user obtains their desired results. Once the desired treatment plan results are obtained, the user can store the final treatment plan for export. The final treatment plan can be exported to the appropriate delivery equipment, linear accelerator, and/or record and verify system. The export of the final treatment plan does not activate the radiation therapy delivery equipment, all information must be verified by the user prior to the initiation of radiation therapy treatment.

The new functionality that is being added with COHERENCE Dosimetrist Workspace v2.2 is described as follows:

VSIM component: DICOM RT Plan and RT structure set can be imported and converted into VSIM compatible objects; Functionality to allow contours/ports editing; Beams eye view (BEV), collimator is rotated as opposed to the underlying image; Improvements to the service user interface; Support for DRR presets for organ-based windowing; Spline fitting mode enabled for editing of contours/blocks; Support for copying of plans is provided; Verify and Record system taskcard integrated; Various tool enhancements within the Localization Mode; Auto fit functionality enhancements.

KonRad component: Compensator support; Plan combination support to combine two IMRT plans to support multiple isocenters or large treatment volumes; DICOM RT dose import and consideration of pre-planned/treated dose; Plan and constraint template editor; Allow to optimize with MLC field size constraints; Support IMRT for Siemens MLC (without using 6.5 cm leaves); Export DVH data in a easily readable format.

Syngo: The original COHERENCE Dosimetrist Workspace software (K022036) was based on the software architecture of the previously cleared syngo software (K010938) and allows for a standardized graphical user interface across Siemens medical products. The syngo-based software design consists of task cards allowing for a selection of modules of common software applications for image acquisition, reconstruction, post-processing, display, and archiving across the Siemens medical product lines.

As part of the Siemens Medical Solutions family of workstations, the syngo based workstations (Oncology Care System calls a "workspace") offers a configurable selection of software applications depending on the type of syngo package that is required for a specific modality. There are multiple applications in common across all Siemens imaging modalities as previously mentioned.

The COHERENCE Dosimetrist Workspace v2.2, will be available as individual purchased options to medical linear accelerator product lines upon receipt of FDA market clearance notification.

This looks like a 510(k) premarket notification for a medical device called COHERENCE Dosimetrist Workspace v2.2. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device identification and contact information.
• Description of the device: How it integrates and enhances functionalities of previously cleared products (VSIM and KonRad).
• Intended Use: As an accessory to linear accelerator systems for radiation therapy planning.
• FDA correspondence: The substantial equivalence determination letter.

There is no mention of specific performance metrics, clinical studies, or engineering studies that would typically be used to demonstrate that the device meets defined acceptance criteria. This submission seems to rely on the substantial equivalence of the combined and enhanced functionalities to previously cleared predicate devices, rather than presenting a de novo performance study with explicit acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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