(120 days)
BrainLAB VectorVision ACL is intended to be an intra-operative 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 a patient's intraoperative image data which is processed by a VectorVision workstation. A virtual individual 3D-surface model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface, supplements the 2D information of the intra-operative image data.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a bone structure, such as tibia and femur, can be identified relative to a CT, fluoroscopic, x-ray or MR-based model of the anatomy.
An example procedure includes but is not limited to:
Planning and drill-tunnel guidance of interosseous canals for ligament repair on the knee.
BrainLAB VectorVision® ACL is a touchscreen-based-intra-operative planning and navigation software, designed for use in anterior cruciate ligament surgey. It is intended to support the surgeon in the planning and drilling of ideal graft canals for the replacement of a torn Anterior Cruciate Liqament (ACL). VVACL uses registered fluoroscopic images and their defined exact spatial position to the patient. These images are acquired intra-operatively using a C-arm. A virtual individual 3D-surface model of the patient's generated through acquiring multiple landmarks on the bone surface, supplements the 2D information of the intra-operative image data.
The provided text is a 510(k) Summary for the VectorVision® ACL device, which is an intraoperative image-guided localization system. It describes the device, its indications for use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, specific device performance metrics, or details of a study proving the device meets acceptance criteria.
The text states:
"VectorVision® ACL 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."
And:
"The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the 510(k)-clearance of VectorVision® CT-free knee (K 021306) and VectorVision® Trauma (K012448)."
This indicates that a validation was performed according to the manufacturer's internal procedures and that the FDA found it substantially equivalent to previously cleared devices. However, the specific details of how "safety and effectiveness" were proven, what the acceptance criteria were, or the results of any performance studies are not provided in this document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document focuses on the regulatory submission process and the determination of substantial equivalence, not the detailed technical performance study results.
§ 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).