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The GraftCage™ ACX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI-L5). The GraftCage™ ACX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage™ ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.

The GraftCage™ ACX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.

The use of bone grafting material with the GraftCage™ ACX is optional.

The GraftCage™ ACX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in bases of spinal trauma/fracture. The GraftCage™ ACX is made from implantable PEEK-OPTIMA (polyetheretherketone) polymer.

The GraftCage™ ACX is basically rectangular in shape. One central (axial) fenestration and one fenestration on each lateral aspect (on certain sizes) provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and for migration after implantation. The device offers lordotic and non-lordotic i.e., parallel configurations. The posterior aspect of both design configurations is tapered, or bulleted, for ease of insertion.

A single threaded hole at the posterior aspect interfaces with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches the threaded hole on the GraftCage™ ACX and allows the surgeon to hold the GraftCage™ ACX while implanting it into the patient.

The provided text is a 510(k) summary for the GraftCage™ ACX, a vertebral body replacement device. It details the device's description, intended use, and comparison to predicate devices, and includes the FDA's clearance letter. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data.

The text primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices rather than providing detailed performance study data against defined acceptance criteria. The statement "Performance data demonstrates that the GraftCage™ ACX meets or exceeds functional requirements for a vertebral body replacement device" is made, but no specifics of this data, the requirements, or the study methodology are provided in this document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the information given. All the requested points (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in this document.

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