(263 days)
The NeuroMate Stereotactic System is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments.
The NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic System are intended for the sterectactic spatial positioning and onlentation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).
NeuroMate assists the surgeon in its operating tasks by providing a stable, accurate, and reproducible mechanical guidance for surgical instruments, while not directly entering in contact with the patient's head. The instrument holder's sterectactic soatial positioning and orientation are determined by the neurosurgeon using an "external" (i.e., not provided by IMMI Inc.) imaging software for stereotactic planning and specific to the intended clinical application.
The NeuroMate Stereotactic System acts like a motorized stereotactic frame driven by the external imaging software supported by a PC or a computer workstation providing visualization of anatomical structures and brain targets specific for the intended application (e.g., 3-D image databases from CT, MR, DSA, PET, SPECT),
Following a carefully prepared stereotactic treatment plan, at the neurosumeon request. the NeuroMate Stereotactic System slowly moves and subsequently nointains an instrument holder proximal to the patient's head: NeuroMate automatically and accurately insure the correct stereotactic angular and spatial positioning of surgical instruments, thereby reducing potential human errors. During most of the duration of a neurosurgical procedure, NeuroMate is motionless and the instrument holder rigidly holds the surgical instrument chosen by the neurosurgeon prior to initiating stereotactic surgery. Only when changing spatial position and/or orientation does NeuroMate actually move. Finally, NeuroMate must be used in conjunction with a stereotactic head ring.
The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:
- electronic and PC circuit boards powered by switching power supplies: .
- an electromechanical 5-axis multiliointed arm displaced by 24V DC motors: .
- a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.
The NeuroMate Stereotactic System's controller has been specifically developed for surgical applications. It includes several functions at the mechanical and software levels, which, in case of dysfunction, quarantee the patient safety and the medical staff safety.
NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:
- an axis controller for each joint: .
- a main controller module coordinating NeuroMate's motion; it performs the . necessary transformations between the Cartesian space and joint space;
- a field bus linking the main controller to the axis controllers; .
- a supervisor module performing all functions related to user interface, and . generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.
The provided document describes the NeuroMate Stereotactic System and its performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather "performance specifications." These are presented as the results of different testing sequences. Based on the "Performance Data" section and Table A (Continued), the following can be constructed:
| Performance Metric | Acceptance Criteria (Implicit from Predicate Devices / Performance Specifications) | Reported Device Performance (NeuroMate Stereotactic System) |
|---|---|---|
| Location 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).