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The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.

This device is intended to be used with supplemental spinal fixation systems.

The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V).
The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.

This document is a 510(k) premarket notification for the RT2 Trabeculite Titanium Cervical Cage System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. It does not contain information about an AI/ML device or its performance study.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study for an AI/ML device, as this document pertains to a medical device (cervical cage) and its mechanical and biocompatibility testing, not an AI or algorithm.

If you have a document about an AI/ML medical device, please provide that, and I will be happy to extract the relevant information.

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