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The Virage® Navigation System Instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. The Virage® Navigation System Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

The Virage Navigation System is comprised of non-sterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems allows the surgeon access to real-time, multi-plane 3D images) thereby providing confirmation of hardware placement.

The provided text does not describe a study involving an AI/ML device or its performance against acceptance criteria. Instead, it describes a 510(k) premarket notification for the Virage Navigation System, which is a stereotaxic instrument used in spinal surgery, not an AI/ML device.

The document focuses on demonstrating substantial equivalence to existing predicate devices (Navigated INFINITY™ Instruments and StealthStation® System) through comparisons of technological characteristics, intended use, and performance data. The "performance data" section primarily discusses accuracy testing of the stereotactic instruments according to ASTM F2554-18 and a clinical validation lab to demonstrate compatibility and safety with existing navigation and power systems.

Therefore, I cannot extract the requested information about acceptance criteria, study details for an AI/ML device (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) because this information is not present in the provided document. The device is a traditional medical instrument, not an AI/ML system.

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