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The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) 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.

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System includes 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ integrated rod, and occipital plates and screws. The implants are composed of titanium alloy, stainless steel, or cobalt chromium molybdenum (CoCr) alloy.

QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX®, CREO®, REVERE®, or BEACON® Systems using corresponding connectors. The QUARTEX™ System includes manual surgical instruments.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) 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.

The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or machine learning device. The document is an FDA 510(k) clearance letter for a QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments.

This document focuses on the mechanical and material equivalence of a surgical spinal system to previously cleared predicate devices. It discusses:

• Device Name: QUARTEXTM Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
• Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
• Regulatory Class: Class II
• Product Code: NKG, KWP, OLO
• Indications for Use: Stabilization of spinal segments, assistance in locating anatomical structures during spinal surgery.
• Performance Data: Mechanical testing (static and dynamic compression bending, static interconnection testing) in accordance with ASTM F1717, ASTM F1798, and FDA guidance. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
• Basis of Substantial Equivalence: Similar technical characteristics, performance, material composition, function, and intended use to predicate devices.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because this information is not present in the provided document.

The document describes material and mechanical testing for a physical surgical implant and navigation instruments, not an AI/ML diagnostic or prognostic device.

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