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BrainLAB uni-knee 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, or MR-based model of the anatomy.

The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.

Example orthopedic surgical procedures include but are not limited to:

• · Unicondylar Knee Replacement
• · Ligament Balancing
• · Range of Motion Analysis
• · Patella Tracking

BrainLAB uni-knee is intended to enable 3 dimensional implant planning and navigation for unicompartimental orthopedic knee surgery. The SW links a surgical instrument tracked by passive markers to a 3D-model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. Uni-knee 2.0 uses the registered landmarks to navigate the femoral and tibial cutting quides to the preplanned position.

Uni-knee 2.0 allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The uni-knee 2.0 software has been designed to read in implant data and tool data from different manufacturers and offers to individually choose the prosthesis during each surgery. The uni-knee 2.0 software registers the patient data needed for planning and navigating intra-operatively. No preoperative CT-scanning is necessary.

The provided text does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria. The document is a 510(k) summary for the BrainLAB uni-knee, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of expert involvement for a test set.
• Adjudication methods.
• Details of a multireader multicase (MRMC) comparative effectiveness study or its effect size.
• Confirmation of a standalone performance study.
• Type of ground truth used for a test set.
• Sample size for the training set or how ground truth was established for it.

The document states:

• "VectorVision® uni-knee 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 some form of validation was performed, but the specifics of that validation, including acceptance criteria, study design, and results, are not detailed in this 510(k) summary. The summary focuses on showing equivalence to predicate devices (K041899, K021306, K052966) as the basis for regulatory clearance.

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