(90 days)
The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
The ExcelsiusGPS® Interbody Module includes hardware and software that enables real time surgical navigation using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, on the patient images. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments are non-sterile, re-usable instruments that are operated manually.
ExcelsiusGPS® Interbody Module instruments include registration instruments. patient reference instruments, and surgical instruments. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification adapters, surveillance marker, surgical instrument arrays, intra-op CT registration fixture, fluoroscopy registration fixture, and dynamic reference bases (DRB and DRB2). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRBs. Surgical instruments are used to prepare the implant site or implant the device, and include instrument handles, disc prep and trial instruments, interbody inserters, and a dilator holder. The Motion Lock End Effector attaches to the robotic arm and provides a rigid attachment connection for a surgical retractor or port.
The provided text is a Fragment and does not contain any information about acceptance criteria or specific studies that prove the device meets these criteria. It details the FDA clearance for the ExcelsiusGPS Spine 1.1 Interbody Module, its indications for use, technological characteristics, and general statements about performance testing. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or effect sizes.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Testing" section states:
- "Surgical simulations conducted on phantom models Sawbone models and registration matrix were used to quantify accuracy in a controlled setting."
- "Human cadaveric quantitative validation under clinically relevant scenarios - Demonstrated system accuracy in navigating interbody fusion devices to the desired location on patient images."
However, no specific data, acceptance criteria, or methodological details like sample sizes, ground truth establishment, or expert involvement are reported for these tests in the provided document.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the studies proving the device meets them based on the provided 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).