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The ARIA Radiation Therapy Management product is a treatment 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 Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

The ARIA Radiation Therapy Management 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 Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through using DICOM, the available image import filters or by means of film digitizers.

The provided text describes the ARIA Radiation Therapy Management (v16.1 MR3) device, which is a treatment plan and image management application. It states that the device was cleared based on non-clinical testing and refers to software verification and validation as the primary performance data.

However, the text does not contain the specific information requested regarding acceptance criteria, reported device performance, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case (MRMC) comparative effectiveness study, standalone performance, or ground truth details for testing and training sets.

The document states:

• "No data from animal studies or clinical tests have been included in this pre-market submission."
• "Since the predicate device was cleared based only on the results of non-clinical testing, no animal or clinical studies were conducted for the subject device. The non-clinical data support the safety of the software verification and validation demonstrate that ARIA Radiation Therapy Management should perform as intended in the specified use conditions."

Therefore, I cannot provide the requested information from the given text. The provided document focuses on regulatory compliance, outlining the device's intended use, comparison with a predicate device, and adherence to software verification and validation testing and various regulatory standards (e.g., IEC 62304, ISO 13485, ISO 14971).

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