(91 days)
Globus Navigation Instruments are intended to be used in the preparation and placement of Globus screws (CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT Stabilization Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Navigation Instruments are nonsterile, reusable instruments including probes, drill bits, drill quides, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
This document is a 510(k) premarket notification from Globus Medical, Incorporated to the FDA for their Navigation Instruments, to be used with the Medtronic StealthStation® System for spinal surgery. The document is an FDA letter granting substantial equivalence. It does not contain information about an AI/ML device or a clinical study that proves the device meets specific acceptance criteria based on AI/ML performance.
Therefore, I cannot provide the requested information for acceptance criteria and the study proving the device meets them for an AI/ML device, as this pertains to a traditional medical instrument and not an AI-driven one. There is no mention of AI, machine learning, or algorithms in the context of device performance or evaluation in the provided text.
The closest relevant sections are "Performance Data" and "Basis of Substantial Equivalence," which discuss design validation testing (rigidity, registration, accuracy) to ensure functionality and compatibility with the Medtronic StealthStation and demonstrate substantial equivalence to predicate instruments. However, these are mechanical and system compatibility tests, not AI performance metrics.
§ 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).