(84 days)
BrainLAB VectorVision is intended to be an intraoperative image quided 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 endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® uni-knee.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Patella Tracking
BrainLAB VectorVision®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. Vector/ision® uni-knee uses the registered landmarks to navigate the femoral and tibial cutting guides to the pre-planned position.
VectorVision® uni-knee allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The VectorVision® uni-knee 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 VectorVision® uni-knee software registers the patient data needed for planning and navigating intraoperatively. No preoperative CT-scanning is necessary.
The provided text is a 510(k) Summary of Safety and Effectiveness for the BrainLAB VectorVision® uni-knee system, dated October 5, 2004. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the specific information requested about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study methodologies.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The document states that the device "has been verified and validated according to BrainLAB's procedures for product design and development" and that "The validation proves the safety and effectiveness." However, it does not detail what those specific acceptance criteria were (e.g., accuracy thresholds, precision measurements) nor does it report the actual device performance against any such criteria.
- No Study Details: There is no mention of specific studies conducted to prove the device meets acceptance criteria. Information regarding test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample sizes, or how training set ground truth was established is entirely absent.
In summary, the provided document is a regulatory submission claiming safety and effectiveness based on internal validation, but it does not provide the details of that validation or the performance data against defined acceptance criteria, as an engineering or clinical study report would.
Therefore, I cannot populate the requested table or answer the specific questions below it. The entire response would be "Not provided in the given text."
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).