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The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implant and instrument components. The Reliance Cervical IBF, the implant component, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The Reliance Cervical IBF spacer is either comprised of PEEK Optima HA with Tantalum markers, or from PEEK Optima LT1 with Tantalum markers. The Reliance Cervical IBF-S spacer (PEEK Optima LT1 or PEEK Optima HA) also incorporates screws to better fixate and stabilize the spine. These screws are manufactured from Titanium alloy as described by ASTM F-136. The device is intended for interbody fusion in the cervical spine and to aid in the surgical correction and stabilization of the spine.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/human reader comparative effectiveness study, standalone algorithm performance, ground truth establishment, or sample sizes for training and testing sets.

The document is a 510(k) premarket notification for the "Reliance Cervical IBF System," which is an implantable medical device for intervertebral body fusion. The FDA review letter and the 510(k) summary describe the device's classification, indications for use, substantial equivalence to a predicate device, and technological modifications (specifically, additional sizes for existing implant designs).

The critical information you requested, such as performance metrics, study design, or expert involvement, is not present in this regulatory submission for an implantable hardware device. Such information would be typical for AI-powered diagnostic or screening tools.

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