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The Navitrack® System -- S&N Image Free Knee is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Identically as in the predicate, the Navitrack® System - S&N Image Free Knee device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicate are to incorporate a new set of instruments to be tracked corresponding to assisting the placement of two new TKR implant lines.

The provided text is a 510(k) summary for the Navitrack® System - S&N Image Free Knee. While it describes the device and its intended use, it does not contain the detailed information required to fill out the table of acceptance criteria, device performance, and study specifics.

The summary explicitly states:
"Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate."

This statement indicates that performance data and tests were conducted, but the results of these tests, specific acceptance criteria, sample sizes, expert qualifications, and other requested details are not included in this document. The document primarily focuses on establishing substantial equivalence to a predicate device based on unchanged fundamental technology, intended use, indications, and operating principles, with modifications mainly for new instrument integration and software enhancements.

Therefore, I cannot generate the requested table and answer the specific questions based solely on the provided text. The document is a summary for regulatory submission, not a detailed study report.

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