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The ExacTrac gating module is an extension to the ExacTrac patient positioning system. ExacTrac Gating repositions the patient relative to the treatment machine according to breathing induced shifts of a target area, and controls the gating of the treatment beam.

ExacTrac® Gating module uses x-ray images acquired before the treatment, to determine the position of fiducial markers that are implanted close to the target region. Via the ExacTrac® infrared cameras, the system can track the breathing motion of IR-reflective markers that are attached to the patient's body. For at least one breathing level of the patient the 3D position of the implanted markers is compared to their expected position based on a previously acquired CT-scan. The patient is then semi-automatically repositioned relative to the treatment machine.

The system generates a signal that can be used to gate a linear accelerator on and off depending on the patients breathing level being in the target region or not.

I am sorry, but the provided text does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study design for a medical device.

The document is a 510(k) summary for the ExacTrac® Gating system, indicating it was found substantially equivalent to predicate devices. It describes the intended use and device description, and states that the device "will be verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."

However, it does not include:

• A table of specific acceptance criteria.
• Reported device performance metrics against those criteria.
• Details about sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Specifics about standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to existing devices, rather than a detailed scientific study report.

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

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