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iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. IFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.

iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System®. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.

This document is a 510(k) summary for the iFuse Implant System - iFuse-Navigation Instrument Set. It describes a medical device, specifically a surgical instrument used with a navigation system for sacroiliac joint surgery, and asserts its substantial equivalence to a predicate device.

The provided text does not contain the detailed information required to answer your specific questions regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K172268) based on having the same intended use/indications for use, similar technological characteristics, and no changes in operating principle, component materials, manufacturing processes, or sterilization method.

The Section "VIII. SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES" states: "Performance testing conducted on the proposed device demonstrates that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The following testing were successfully performed for the 4.0 mm Navigation Broach: registration with Medtronic StealthStation and dimensional analysis."

This is a very high-level summary and does not provide the specific acceptance criteria or the reported performance data in a quantitative manner that would allow for the creation of the requested table. It also does not describe the study methodology in enough detail to answer questions about sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study that proves the device meets them based solely on the provided text. The document indicates that testing was performed, but it does not present the results or the details of those tests.

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