(79 days)
BrainLAB VectorVision hip is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision or a Ci™ workstation or 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 hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR) Revision surgery of TJR Tumor resection and bone/joint reconstruction
BrainLAB VectorVision®hip 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 either based on a patients preoperative image data or generated through acquiring multiple landmarks on the bone surface. VectorVision® hip uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon.
VectorVision® hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. The VectorVision® hip software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. The VectorVision® hip software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. The System can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon. Using the CT based module the patient data can be used additionally for surgery, the patient data is then is provided by the CT data stored on a standard data storage media.
The provided text is a 510(k) Summary for the BrainLAB VectorVision® hip. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain specific details about acceptance criteria, a standalone study proving performance against those criteria, or information on reader studies.
Therefore, I cannot fully answer your request based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study effect sizes is not present.
The document states:
"VectorVision® hip 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 internal validation was performed, but the details of this validation (including specific acceptance criteria and how they were met) are not included in this summary.
If such information were present, it would typically be under sections describing performance data or validation studies.
§ 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).