(118 days)
The StealthStation® System, with Station Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement
- o Iliosacral Screw Placement
o Interbody Device Placement
The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
The StealthStation S8 Spine Software v1.0.0 is an image-guided system (IGS) intended to aid in precisely locating anatomical structures during open or percutaneous neurosurgical and orthopedic procedures, specifically for spinal implant procedures such as pedicle screw placement, iliosacral screw placement, and interbody device placement.
Here's a breakdown of its acceptance criteria and the study proving it meets these criteria:
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against specific accuracy requirements.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) |
|---|---|---|
| Acceptance Criteria | Mean |
§ 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).