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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fration, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Spineology Rampart One Lumbar Interbody Fusion System. This documentation is for a medical device (lumbar interbody fusion system), not an AI software/device. Therefore, the content does not discuss acceptance criteria or studies related to AI device performance.

The document details the device's classification, indications for use, comparison to predicate devices, and non-clinical (benchtop mechanical) testing conducted to demonstrate substantial equivalence. It does not contain information about clinical studies with human subjects, ground truth establishment, expert adjudication, or MRMC studies that would be relevant for an AI/software device.

As such, I cannot extract the information required by your prompt, as it is designed for AI/software device evaluation, and the provided document pertains to a physical medical implant.

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