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Rampart-T implants are 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 six months of non-operative treatment.

Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Spineology Rampart™-T Interbody Fusion System. It primarily discusses the device's substantial equivalence to predicate devices and does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML performance.

The "Performance Data" section mentions that the device "previously underwent performance testing" in accordance with FDA guidance and ASTM standards (F2077 and F2267). This testing included:

• Static compression shear
• Shear
• Dynamic axial and shear compression
• Subsidence
• Expulsion

However, this refers to mechanical and biocompatibility testing of the interbody fusion device itself, an orthopedic implant, and not performance criteria for an AI/ML device. The document also states this testing was "previously submitted and reviewed by the FDA," implying the detailed results and acceptance criteria for these mechanical tests are not included within this particular submission.

Therefore, none of the requested information regarding acceptance criteria and studies for an AI/ML device's performance can be extracted from this document, as it is related to a traditional medical device (an intervertebral body fusion device).

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