Search Results

The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

The OptiMesh Lordotic device incorporates an asymmetrical dual chamber mesh with a larger chamber in the anterior portion of the disc space than in the posterior. Due to the asymmetry of the two mesh chambers when filled, the implant is designed to result in a lordotic shape.

The provided document is a 510(k) summary for the OptiMesh Multiplanar Expandable Interbody Fusion System. This document does not describe a study involving an AI/CADe device, human readers, or a test set with ground truth established by experts.

Instead, this document describes a medical device (an intervertebral body fusion system) and its mechanical and design properties. The non-clinical testing performed focuses on benchtop performance ASTM testing and risk assessment to demonstrate equivalence to a predicate device.

Therefore, I cannot provide the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, or adjudication methods, as these concepts are not applicable to the information presented in this 510(k) summary.

In summary, the provided document does not contain information about an AI/CADe device study to fulfill the prompt's requirements.

Ask a specific question about this device