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When used as a cervical intervertebral body fusion device, the Summit Spine Channel Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g.anterior cervical plate)and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage

The Summit Spine Channel Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Summit Spine cervical interbody implant, which may be implanted as a single device via an anterior approach. The Summit Spine Channel Cervical Interbody Fusion System implant components are made of polyether ether ketone (Evonik Vistakeep) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This is a 510(k) summary for the Summit Spine Channel Cervical Interbody Fusion System, a medical device. This document does not describe a study involving device performance metrics relevant to an AI/Software as a Medical Device (SaMD) product. Instead, it focuses on the substantial equivalence of a physical implantable device to a predicate device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/SaMD product's performance cannot be extracted from this document. The document describes mechanical performance testing for the physical interbody fusion device, not the performance of a software algorithm.

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