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Instruments are tracked by a passive marker sensor system that acquires and is interfaced with computer hardware and software. This enables a surgeon to use instrumentation tracked by a virtual 3D computer image for precise bone cuts and accurate navigation of the position of implants during minimally invasive orthopaedic knee reconstructive procedures. The system is indicated for any orthopaedic surgical intervention in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a bone, is required, and may be used relative to a CT or MR based model of the anatomy.

Example orthopaedic procedures for these instruments include, but are not limited to:

• Total Knee Replacement
• Unicondylar Knee Replacement
• Ligament Balancing
• Range of Motion Analysis
• Cruciate Ligament Surgery
• Patella Tracking

DePuy CAS Knee Instruments are computer recognized by application specific Ci TKR/UKR, VectorVision CT-Free Knee and VectorVision Knee hardware/software owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery. BrainLAB designed the Ci System exclusive to DePuy specific instrument/implant data tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and tibial cutting guides and implants for the most accurate position.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and device performance. The document describes the "DePuy CAS Knee Instruments" and states its intended use and regulatory classification, along with the basis for substantial equivalence to other marketed devices. However, it does not include:

• Specific acceptance criteria in a quantitative or qualitative manner.
• Reported device performance metrics against any such criteria.
• Details of a study design, sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document is a 510(k) summary and FDA clearance letter, which typically focuses on regulatory equivalence rather than a detailed presentation of performance study results against predefined acceptance criteria.

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