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Ci TKR/UKR is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.

Example orthopedic surgical procedures include but are not limited to:

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

Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.

The CAS Knee Instrumenation (K-043223) developed and manufactured by DePuy is integrated in the Ci TKR/UKR software. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery.

The provided text is a 510(k) Summary for the Ci TKR/UKR device, an image-guided localization system for knee surgery. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

The available information focuses on the regulatory submission and FDA clearance based on substantial equivalence to existing devices, rather than a detailed performance study with explicit acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study proving these criteria, based on the provided text. The document states:

"Ci TKR/UKR has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."

This indicates that validation was performed, but the specifics of that validation, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not included in this publicly available 510(k) summary.

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