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The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

ARIA Radiation Oncology is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatments planning, simulation, and plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. ARIA Radiation Oncology is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.

ARIA Radiation Oncology (K042956) has been modified to introduce a new component called MIRS (Multimodality Image Registration and Segmentation). MIRS provides components to perform various types of image registration and segmentation to facilitate and support the clinical goals of image guidance and adaptation including: multimodality image review capabilities, deformable and rigid multimodality image, structure segmentation and approval and structure propagation between registered images.

ARIA Radiation Oncology is based on the client-server architecture, and thus all ARIA Radiation Oncology clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision/ARIA).

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the ARIA Radiation Oncology device with the MIRS component.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria. While it mentions MIRS (Multimodality Image Registration and Segmentation) provides capabilities for image registration and segmentation, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample size, data provenance, number or qualifications of experts, or adjudication method for a test set.
• Information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Details on standalone (algorithm only) performance.
• The type of ground truth used in any studies.
• Sample size or how ground truth was established for a training set.

The summary primarily states the purpose of the MIRS component and its functionalities (image review, deformable and rigid registration, structure segmentation and approval, structure propagation), but not the quantitative performance metrics or the studies conducted to validate these.

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