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The RadioCameras™ System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System 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. The RadioCameras™ System uses optical tracking of infrared markers as the method of locating the position of the patient. The RadioCameras™ System consists of a high resolution linear CCD camera array, computer workstation, an optical Positioner, and an optical calibration jig.

The provided text is a 510(k) summary and an FDA clearance letter for the RadioCameras™ Patient Positioning System. It describes the device's purpose and general claims of substantial equivalence butdoes not contain any information about acceptance criteria, specific performance metrics, or details of a study demonstrating its performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states that the device "was shown to be substantially equivalent to other commercially available patient positioning systems" for its intended use, which is general information about regulatory clearance rather than a detailed performance study.

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