(92 days)
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. It provides quidance of any surqical 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 a robot stand with a compact robotic arm and a touchscreen positioned close the operating table. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate quidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Brain application, a robotized image-guided device for neurosurgery. It's an FDA 510(k) submission seeking substantial equivalence to a previously cleared version of the same device. The submission focuses on non-clinical performance data to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for each test in a formal table with pass/fail. However, it does outline the tests performed and the results, implying that the predicate device's performance levels define the acceptance criteria for the new version. The most specific performance metric provided is for accuracy.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System applicative accuracy (In vitro) | 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).