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The ClariVy" 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 implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

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

The purpose of this 510(k) submission is to introduce the ClariVy™ OsteoVy™ PEKK Cervical IBF configuration. The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVy™ Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVy™ Cervical IBF and ClariVy™ NanoVy™ Ti may also include Titanium alloy bone screws to secure the device to the vertebral body. The ClariVy™ OsteoVy™ PEKK Cervical IBF is made from OXPEKK.

I am sorry, but the provided text does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter for a medical device (ClariVy™ Cervical IBF System), which focuses on the administrative aspects of regulatory clearance and comparison to predicate devices, rather than a detailed study report on acceptance criteria, device performance, or clinical trial methodology.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, or expert involvement for a test set.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• Information on the type of ground truth used.
• Details regarding the training set, including its sample size or how its ground truth was established.

The "Non-Clinical Testing" section
{4} mentions mechanical testing according to ASTM standards, but it doesn't provide specific performance results against acceptance criteria. There's no mention of any study involving AI or human readers, or any other kind of clinical or image-based performance evaluation that would necessitate the information requested in your prompt.

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