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The BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications in x,y,z directions and in azimuthal and declination angles requiring coordinate-accurate imaging-guided target localization and instrument guidance.

BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "BrainLAB Stereotactic Arc," and it primarily focuses on the regulatory approval and substantial equivalence to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes for test or training sets.
• Data provenance.
• Details about experts for ground truth or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used.
• How ground truth was established for a training set.

The document states the device's indications for use, but does not elaborate on the specific performance metrics or studies conducted to demonstrate its efficacy or accuracy.

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