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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 ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.

The provided text is a 510(k) clearance letter from the FDA for the BrainLAB ExacTrac Patient Positioning System. It ays that the device is substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain the acceptance criteria or the details of any study used to prove the device meets acceptance criteria.

The 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive performance studies with defined acceptance criteria in the same way a Premarket Approval (PMA) would. While the applicant would have submitted data demonstrating the device's performance, these specific details (acceptance criteria, study design, sample size, ground truth, expert qualifications, etc.) are generally described in the 510(k) summary and full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the actual 510(k) summary document (K983660) for the ExacTrac system, which would likely contain the performance data and testing details.

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Frameless stereotactic cranial neurosurgery and intraoperative would be surgical guidance.

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The provided text is a 510(k) clearance letter from the FDA to BrainLAB USA, Inc. for their "VectorVision" device. This document primarily focuses on regulatory approval and does not contain the detailed performance study information, acceptance criteria, or sample sizes you've requested.

Therefore, I cannot provide the information you asked for based on the input text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the specifics of the underlying validation studies.

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