(88 days)
The device is intended for the spationing 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-quided device that assists the surgeon during brain surgeries. It provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments 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 touch screen. 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 5.1 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 guidance 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 and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for a diagnostic algorithm).
Instead, this document focuses on demonstrating substantial equivalence based on engineering and quality control tests rather than clinical performance of an AI algorithm making diagnostic or treatment recommendations. The "performance data" section primarily discusses electrical safety, EMC, software verification, and biocompatibility, along with a statement about system applicative accuracy derived from the predicate device's testing.
Given the information provided, here's a breakdown of what is and is not available in the document regarding your request:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "performance data" that could be interpreted as a performance criterion is the "System applicative accuracy."
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Inherited from Predicate) |
|---|---|
| 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).