(182 days)
The Remex Spine Surgery Navigation System II, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative quidance system to enable open or percutaneous image quided surgery by means of registering intraoperative 2D fluoroscopic projections to preoperative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
The Remex Spine Surgery Navigation System II, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.
Apologies, but the provided text from the FDA 510(k) clearance letter and the associated 510(k) summary for the "Remex Spine Surgery Navigation System II" does not contain the detailed information required to fulfill the request regarding acceptance criteria and the study that proves the device meets the acceptance criteria.
Specifically, the document states that "Performance Data Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions. Below is a summary of all performance tests which should carried out on the subject device to demonstrated that the subject device performs as safely and effectively as the predicate device."
It then lists several tests:
- Software
- Electrical Safety
- Electromagnetic Compatibility
- Accuracy
- Risk Assessment
- Design Verification
While "Accuracy" is listed, the document does not provide the acceptance criteria for this accuracy test (e.g., "positional accuracy must be within X mm") nor does it report the actual device performance results against these criteria. It simply states that accuracy was "evaluated in accordance with ASTM F2554-18."
Therefore, I cannot generate the requested information based solely on the text provided. The document outlines what types of tests were performed to demonstrate substantial equivalence, but not the specific quantitative acceptance criteria or the measured performance of the device against those criteria.
To answer your prompt, I would need a document that includes sections detailing:
- Specific, quantitative acceptance criteria for performance metrics (e.g., accuracy, precision).
- Reported performance results of the device against those criteria.
- Details about the study design for accuracy (e.g., sample size, data provenance, ground truth establishment, expert qualifications, etc.).
Without that missing information, I cannot complete the table or provide the requested details about the study.
§ 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).