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Stereotaxic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon manually to guide standard neurosurgical instruments.

A stereotaxic system with a computer-controlled mechanical arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

The provided documents do not contain the details required to complete your request. Specifically, the 510(k) summary for the "PathFinder Image Guided Surgical Localiser" (K041477) focuses on its equivalence to a predicate device, its intended use, and compliance with safety and EMC standards. It does not include information about:

• Acceptance criteria and reported device performance: There is no table or description of specific performance metrics or thresholds the device must meet. The document states "no substantive change in performance" compared to the predicate, but doesn't quantify it.
• Study details:
  • Sample size for test set.
  • Data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study or its effect size.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training set.
  • How ground truth for the training set was established.

The document primarily asserts equivalence based on technological characteristics and safe use, rather than presenting a performance study with detailed acceptance criteria and results.

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