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The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures on head and neck lesions outside the cranium. The RadioCameras™ Head/Neck Application uses fiducial markers on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the treatment isocenter relative to the LINAC isocenter. The RadioCameras™ Biteblock System Head/Neck Application consists of a high resolution linear CCD camera array, computer workstation, a biteblock optical positioner, and an optical calibration jig.

The provided text is a 510(k) summary for the RadioCameras™ System Head/Neck Application and a clearance letter from the FDA. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. The document primarily focuses on regulatory classification, indications for use, and substantial equivalence to predicate devices, without detailing the technical validation studies performed.

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