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Neo Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.

The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The NEO Cage System™ is an intervertebral fusion device with autogenous bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.

The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surqical technique. The cages of the Neo Cage system are made of titanium alloy according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are single use only and delivered sterile. The Instruments are to be used for the implantation of the above mentioned medical devices.

This document is a 510(k) premarket notification for a medical device (Neo Cage System™), which is a regulatory submission to the FDA. It does not include data from a study proving a device meets acceptance criteria, an MRMC study, or AI performance data.

The document states: "Clinical Evaluation: Clinical studies were not required, based upon review and evaluation of scientific literature, comparison with similar devices and non-clinical performance data."

Therefore, I cannot provide details on the specific points requested regarding acceptance criteria and performance studies (e.g., sample size for training/test set, expert ground truth establishment, MRMC studies, standalone performance), as these were not part of this 510(k) submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Mechanical Testing: Performed according to ASTM F2077 and F2267, and ISO 17853, covering static and dynamic compression, shear, torsion, subsidence, and wear testing.
• Biocompatibility: Evaluated per ISO 10993-1, including chemical analysis (ISO 10993-18) and cytotoxicity (ISO 10993-5).
• Sterilization Validation: Per ISO 11137-2 (VDmax25 method) for a SAL of 10-6.
• Pyrogenicity: LAL-Test results

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