Search Results

Xenco Medical Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>=20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Xenco Medical device.

Not Found

I am sorry, but the provided text is a government document (FDA 510(k) clearance letter and Indications for Use) for a medical device called the "Xenco Medical Lumbar Interbody System." This type of document does not contain the information you are requesting about acceptance criteria from a study, device performance in terms of metrics like sensitivity/specificity, or details about the study design (sample size, experts, ground truth, MRMC studies, etc.).

This document focuses on:

• The FDA's determination of substantial equivalence to a legally marketed predicate device.
• The intended use and indications for the device.
• Regulatory class and product code.
• General controls and applicable regulations.

Therefore, I cannot provide the requested information based on the text provided.

Ask a specific question about this device