Search Results

The Leva™ Spacer System is indicated for intervertebral body fusion 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 radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ 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 prior to treatment with an intervertebral body fusion device.

The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

This document is a 510(k) Summary for the Leva™ Spacer System, a medical device for intervertebral body fusion. It's a regulatory submission to the FDA for market clearance, not a study report demonstrating the device meets acceptance criteria derived from a clinical or diagnostic performance study.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details cannot be extracted from this document because it describes a submission based on substantial equivalence to a predicate device, not a direct performance study against defined acceptance criteria in the manner typically associated with AI/diagnostic device applications.

Specifically, the document states:

• "Finite Element Analysis was used to demonstrate the substantial equivalence of the Leva™ Spacer System to its predicate."
• "Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Leva™ Spacer System has been shown to be substantially equivalent to the predicate devices... and does not present any new issues of safety or effectiveness."

This means the "performance data" relied on engineering analysis (Finite Element Analysis) to show equivalence to an already approved device, rather than patient-level data or a clinical study with quantifiable metrics against specific acceptance criteria.

Ask a specific question about this device