Search Results

The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fission procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The Leva® Anterior Expandable Spacer is an expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium per ASTM F67. The Leva® Anterior Expandable Inserter, a reusable surgical instrument, expands the spacer (which is provided in a collapsed form) in situ to a predefined height. To accommodate the anatomical needs of a variety of patients, the spacer is available in a range of sizes. The superior and inferior surfaces of the spacer are convex with a lordotic angle to conform to the vertebral endplates, and ridges on both surfaces help resist expulsion. The spacer is designed to accommodate autogenous bone graft material.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Leva® Anterior Expandable Spacer System), which is an intervertebral body fusion device. This documentation focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material properties, rather than the performance of an AI or diagnostic device that would involve an AI algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI device performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for such studies.

The acceptance criteria in this document relate to the physical and mechanical properties of the implant, such as:

• Static and dynamic axial compression (per ASTM F2077)
• Static and dynamic compression shear (per ASTM F2077)
• Subsidence (per ASTM F2267)
• Cadaveric validation

Since the input doesn't provide data for an AI-related medical device study, I cannot generate the requested table and information.

Ask a specific question about this device