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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 (CI-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 radior 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.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

The provided text is a US FDA 510(k) K231850 clearance letter for the QUARTEX® Occipito-Cervico-Thoracic Spinal System and ExcelsiusGPS® Instruments. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria in the context of an AI/medical device standalone or comparative effectiveness study.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available within the provided text.

The document mentions "Verification and validation testing were conducted to confirm implant placement accuracy with ExcelsiusGPS®" under the "Performance Data" section. However, it does not provide any specifics about these tests, methodologies, acceptance criteria, or the results of these tests.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the detailed questions about the study proving the device meets acceptance criteria.

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