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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments made of surgical stainless steel. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The provided text describes the CoreLink Navigation Instruments, but it does not contain the specific information requested about acceptance criteria and the detailed study that proves the device meets those criteria.

The document is a 510(k) Premarket Notification from the FDA, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. While it mentions "Performance Data" and "Testing to ASTM F2554-10," it does not elaborate on the specific acceptance criteria, reported performance values, study design details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), or training set information.

Therefore, I cannot fulfill your request as the necessary details are not present in the provided text.

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