(78 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 surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
The subject ROSA ONE Spine application is identical to the most recent clearance (K182848) with the exception of an additional calibration step (software) and stand-alone arrays (instrumentation).
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen .
- a camera stand with an optical navigation system and a touchscreen .
Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro testing) | Robot arm positioning 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).