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CERVICAL INTERBODY FUSION DEVICE

When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.

LUMBAR INTERBODY FUSION DEVICE

When used as a lumbar intervertebral body fusion implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.

VERTEBRAL BODY REPLACEMENT

When used as a vertebral body replacement (VBR) implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5, for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5). Additionally, the VBR implant is intended to be used with bone graft.

The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. Implant-specific and 510(k) exempt orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the system.

The provided text is a 510(k) premarket notification letter from the FDA regarding an Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System. It details the device's indications for use and a summary of the submission. Crucially, this document explicitly states that "No new performance data was provided to support substantial equivalence" and "A literature analysis was performed and no new performance data was required to support substantial equivalence."

Therefore, I cannot extract the information required for acceptance criteria and the study that proves the device meets them from this document. The device in question was cleared based on its substantial equivalence to previously marketed predicate devices, with no new performance data submitted to demonstrate its own performance against specific acceptance criteria. The submission focused on expanding an indication for use for bone graft types and administrative changes, not on new performance studies of the device itself.

In summary, the document does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets them, as no such new performance study was conducted or submitted for this particular 510(k) clearance.

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