(312 days)
The Bengal® Stackable Cage System is indicated for use in the thoracolumbar spine (i.e. T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation.
The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.
The Bengal Stackable Cage System is a VBR Spinal System designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period, as well as for treating fractures of the thoracic and lumbar spine.
The structure of the polymer/carbon-fiber composite implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and medial-lateral directions, which resist rotation and migration. The polymer/carbon-fiber composite implants have cavities to accept packing of bone graft.
The provided text is a 510(k) summary for the Bengal® Stackable Cage System, primarily seeking to expand its indications for use to include the cervical spine. However, it does not contain specific acceptance criteria or performance data for an AI/CADe device.
Instead, it describes a medical device (a spinal implant) and relies on a "literature analysis of published clinical data" to support the modified indication for use. It explicitly states, "No additional testing was required as the technological characteristics are consistent and or similar with those of the primary predicate device and the additional predicate device."
Therefore, based solely on the provided text, I cannot provide the information requested about acceptance criteria and a study proving device performance for an AI/CADe device.
If you are looking for information about the Bengal® Stackable Cage System itself, I can elaborate on its description and intended use from the text. But for AI/CADe device performance, this document does not contain that information.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.