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TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.

In summary, the software is designed to provide a threedimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided prostate boundary dictates the seed locations. A treatment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.

I am sorry but the provided text does not contain the detailed information necessary to complete all sections of your request. Specifically, the acceptance criteria and the comprehensive study details (sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC study results, standalone performance, and ground truth types) for the device are not described. The document is primarily a 510(k) summary and an FDA clearance letter, which focus on the device's substantial equivalence to a predicate device and its intended use, rather than a detailed performance study report.

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