(226 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by 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 surgery may be appropriate.
The ROSA BRAIN device is a robotized platform providing guidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands. ROSA BRAIN is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning. An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device. In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument lenath). During surgery, the device provides accurate and rigid guidance of the required instrument according to the previously completed planning. The optical distance sensor used with the ROSA BRAIN is susceptible to Electrostatic Discharge (ESD). The ROSA BRAIN device is intended to be used with anti-static sterile drapes which are designed for the device and listed in the list of compatible devices. The anti-static sterile drapes are mitigations to ROSA Brain device ESD immunity.
The provided text is a 510(k) summary for a medical device called ROSA BRAIN (v3.0.0.5), a computer-assisted surgical device (stereotaxic instrument). This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device (ROSA BRAIN v3.0.0.0).
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than setting new, specific acceptance criteria for this version's performance at a detailed algorithmic level. The performance data provided are primarily for safety and general functional aspects, and a key 'performance' metric mentioned is system applicable accuracy.
| Test Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Performance demonstrated to be substantially equivalent to the predicate device. Specific numerical targets for accuracy are given for the predicate and are implicitly the acceptance criteria for the new device. | - 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).