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The Zavation Spinal 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems 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 Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross 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 pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

Ask a specific question about this device