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For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.

PROFA an Optical Patient Contouring Device

The provided text is a 510(k) clearance letter from the FDA for the PROFA an Optical Patient Contouring Device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory approval document and not a technical summary of the device's validation. Therefore, it is impossible to extract the requested information from the provided text.

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