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ELLIPSE® and PROTEX® CT 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 other occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm 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 and occipital plates, CAPITOL™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537). Mixing of stainless steel implant components with different materials is not recommended for metallurgical, mechanical and functional reasons.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295) or stainless steel (per ASTM F138). Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants.

This document, a 510(k) summary for the ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems, does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

The document describes a medical device clearance (K150552) for spinal implants, specifically requesting additional indications for the use of screws in the posterior cervical spine. The performance data section refers to mechanical testing of the physical implants per ASTM F1717 (static/dynamic compression bending, static/dynamic torsion) to demonstrate substantial equivalence to predicate devices, not performance evaluation of a software algorithm.

Therefore, I cannot extract the requested information using the provided text. The questions you posed (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are relevant to the evaluation of AI/ML software/devices, not to the mechanical spinal implants described in this 510(k) summary.

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