(214 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
While the provided document is a 510(k) premarket notification for the ROSA Spine device, it primarily focuses on establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with detailed acceptance criteria and ground truth establishment for a diagnostic or AI-driven medical device. The ROSA Spine is described as a computer-controlled electromechanical arm for surgical guidance, not a device that makes diagnoses or predictions based on medical images in the way an AI algorithm might.
Therefore, many of the requested details, particularly those related to "AI improvement," "multi-reader multi-case studies," "ground truth establishment," and "training sets" are not applicable or explicitly stated for this type of surgical guidance system's 510(k) submission.
However, I can extract the relevant performance data and address the questions to the best of my ability based on the provided text, making it clear where the information is not present or not applicable.
Here's an attempt to answer your questions based on the provided document:
Device: ROSA Spine (a computer-controlled electromechanical arm for spinal surgical guidance)
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present these as "acceptance criteria" in a formal table with pre-defined thresholds the way an AI or diagnostic device might. However, it does provide performance metrics tested and reported for the device and its predicates. I will interpret "acceptance criteria" as the performance levels achieved that demonstrate equivalence and safety/effectiveness for this type of device.
| Performance Metric | Acceptance Criteria (or equivalent reported predicate performance) | Reported Device Performance (ROSA Spine) |
|---|---|---|
| Robot Absolute 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).