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The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.

This document is a 510(k) premarket notification for a medical device, the INNESIS PEEK TL CAGE. It does not contain information about the acceptance criteria and study proving device performance in the context of an AI/human-in-the-loop study. Instead, it details the substantial equivalence of this intervertebral body fusion device to predicate devices based on materials, design, indications for use, operational principles, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for device performance related to AI or multi-reader multi-case studies, as that information is not present in the provided text.

The closest relevant information, regarding device performance in a general sense, is about mechanical testing to demonstrate substantial equivalence:

Summary of Mechanical Testing:

• Test Standards:
  • Static and dynamic axial compression test: ASTM F2077-11
  • Static compression shear test: ASTM F2077-11
  • Static and dynamic torsion test: ASTM F2077-11
  • Static subsidence test: ASTM F2267-04
  • Expulsion test: ASTM Draft Standard F04.25.02.02.
• Conclusion: The tests performed demonstrated that the INNESIS PEEK TL Cage met required mechanical strengths and that any minor geometric differences from predicate devices did not impact performance. The device was found substantially equivalent to the predicate devices.

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