(90 days)
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 registration 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 saving even more time for the physician and the rest medical staff.
The provided text is a 510(k) premarket notification for the Exomio Radiation Therapy Simulation System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT contain the detailed information necessary to answer your questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications.
The document is primarily an administrative approval letter from the FDA. It confirms that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to a predicate. It does not elaborate on the specific studies and data that led to this determination.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, details of MRMC studies or standalone performance studies, or how ground truth was established, based solely on the provided text.
The information you are requesting would typically be found in the detailed technical documentation submitted as part of the 510(k) application, which is not included in these excerpts.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.