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The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment planning tools to the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3D visualization of the virtual treatment setup. Moreover, it includes useful treatment setup export capabilities to enable the communication with compatible medical devices.

Exomio is a programmable (Software) medical device aiming to fully provide the physicians with necessary visualisation and image manipulation tools to prepare the patient's RT simulation virtually in absence of the physical patient and the physical simulator. This is done using the patient's CT data set, including the attached on the patient's skin reqistration markers, instead of the physical patient. This process it called virtual simulation and Exomio, as well as other similar systems, is called CT-based or Virtual Radiation Treatment Simulation System.

Exomio provides tools to support clinician's decision making through the use of enhanced visualization of the patient data set and treatment parameters. 3-D visualization provides an excellent overview of the patient's anatomy. In addition, the relation between treatment beams and tumor can be investigated in detail using Exomio's navigation tools. All this unique functionality is provided to the clinics with aim the overall improvement of the RT simulation process.

Exomio is able, using the DICOM standard, to export all parameters necessary for the treatment of the patient as well as the images to other devices supporting DICOM RT Plan and Structure Set. This way the whole procedure becomes a lot faster savinq even more time for the physician and the rest medical staff.

The provided document is a 510(k) submission for a medical device (Exomio Model 2.0 SP1 Radiation Therapy Simulation System) and an FDA clearance letter. It describes the device's intended use and substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study to prove the device meets these criteria. This type of information is typically found in detailed technical reports, validation studies, or clinical trial summaries, which are not present in this 510(k) summary.

The document primarily focuses on establishing substantial equivalence to a predicate device, which usually means demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as a previously cleared device, often without requiring extensive new clinical studies if the differences are minor.

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