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The Orthopedic Alliance Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion ( pseudarthrosis ).

The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Orthopedic Alliance Spine System is a top-loading multiple component posterior spinal fixation system which consists of fixed and swivel-head pedicle screws, rods, locking cap screws, and a transverse linking mechanism. The screws are available in various lengths and diameters. The swivel-head pedicle screws are assembled at the factory to provide variable axis screw assemblies. The rods are 4mm in diameter and available in various lengths. The locking cap nuts are applied to the screws after the rods are placed to lock them into position. Cross linkage braces are also available to connect from one rod to another in bilateral constructs.

Materials: The devices are manufactured from CP Titanium and Ti6Al-4V ELI Titanium alloy per ASTM and ISO standards.

Function: The Orthopedic Alliance Spine System functions to provide immobilization and stabilization of the spine as an adjunct to fusion in the treatment of chronic instabilities or deformities of the spine.

The provided text describes a spinal fixation system, not a device that would typically have acceptance criteria in the context of AI/ML performance metrics. The document is a 510(k) premarket notification for the "Orthopedic Alliance Spine System," which is a medical implant (pedicle screw system).

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets), which are typically associated with performance evaluations of AI/ML-driven diagnostics or imaging analysis devices, is not applicable to this submission.

The document discusses:

• Device Description: Multi-component posterior spinal fixation system (screws, rods, locking caps, transverse linking mechanism).
• Materials: CP Titanium and Ti6Al-4V ELI Titanium alloy.
• Intended Use/Indications: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal instabilities and deformities (e.g., degenerative spondylolisthesis, fracture, scoliosis, spinal tumor).
• Substantial Equivalence: Comparison to predicate devices (Xia Spinal System, Global Spinal Fixation System, Synergy Spine System). The basis for clearance is that "There are no significant differences between the Orthopedic Alliance Spine System and other spinal fixation systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use."

No performance study in the sense of accuracy, sensitivity, or specificity (as would be relevant for an AI/ML device) is mentioned. The clearance is based on substantial equivalence to existing predicate devices, implying that the device meets existing safety and effectiveness standards through its design, materials, and intended use being similar to already approved devices, rather than through a novel performance study proving specific diagnostic or analytical metrics.

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