(90 days)
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic guidance features: freehand navigation and robotic guidance.
The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.
The robotic guidance feature utilizes the same principle of optical position determination technology. The system componentss include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the SURGIVISIO Device:
Note: The provided text is an FDA 510(k) summary, which often focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing the design and execution of individual performance studies, especially clinical ones. As such, some of the requested information (like specific sample sizes for test/training sets, detailed expert qualifications, adjudication methods, and MRMC study details) is not explicitly present or fully elaborated in this type of document. I will extract what is directly stated and highlight where information is absent.
Acceptance Criteria and Device Performance
The acceptance criteria for the SURGIVISIO Device are implicitly defined by its comparison to the predicate devices, specifically regarding "System accuracy" and "Device accuracy." The device claims to meet these criteria.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate) | Reported Device Performance (SURGIVISIO Device) |
|---|---|---|
| Freehand Navigation Feature | ||
| Mean navigation accuracy | ± 2mm point (tip) displacement and ± 2° angular axis displacement | Mean navigation accuracy of ± 2mm point (tip) displacement and ± 2° angular axis displacement |
| Robotic Guidance Feature | ||
| Device accuracy |
§ 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).