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The Zavation eZspand™ Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ Interbody System implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.

The Zavation eZspand™ Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

The Zavation eZspand™ Interbody System devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior, transforaminal or lateral approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) summary for the Zavation eZspand™ Interbody System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study or AI/software-related acceptance criteria.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device), sample size for a test set, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, is not present in this document.

This document details:

• Device Name: Zavation eZspand™ Interbody System
• Indications for Use: Spinal fusion procedures with autogenous bone graft in skeletally mature patients at L2-S1 for degenerative disc disease (DDD) with up to Grade I spondylolisthesis, after six months of non-operative treatment, used with supplemental internal fixation.
• Materials: Titanium alloy (Ti-6A1-4V), cobalt chrome alloy (Co-28Cr-6Mo), and medical grade PEEK Zeniva ZA-500 or Magnolia PEEK.
• Predicate Devices: K191339 Zavation eZspand™ Interbody System, K200084 Zavation IBF System, K192115 Sable™ Expandable Spacer.
• Technological Characteristics: Similar to predicate devices in basic design (lumbar interbody fusion device with expansion mechanism), sizes, materials, mechanical safety and performance, and intended use.
• Performance Data (Biomechanical): Biomechanical tests were performed according to ASTM standards for intervertebral body fusion devices, including Static/Dynamic Axial Compression, Static/Dynamic Shear, and Measuring Load Induced Subsidence. This demonstrates mechanical substantial equivalence to predicate devices.

In summary, the document describes the mechanical testing conducted on the device, not a study evaluating its performance in a clinical setting against acceptance criteria typical for AI/diagnostic devices.

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The Zavation System is intended to provide immobilization and stabilization of spinal segments in sketally mature patients as an adjunct to fusion in the tollowing acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and rod connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors, offsets, and connectors.

This document is a 510(k) premarket notification for the Zavation Spinal System. It is primarily a regulatory submission for a medical device and therefore does not contain information about an AI/ML device, its acceptance criteria, or a study proving it meets them.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery. The performance data section refers to "biomechanical testing including static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip of rod connectors was tested according to ASTM F1798." These are standard mechanical engineering tests for implants to ensure their structural integrity and performance, not statistical or clinical studies for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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