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This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.

I am sorry, but the provided text describes a Cervical Interbody Fusion System, which is a medical device used for spinal fusion. The text details its regulatory classification, indications for use, materials, and non-clinical performance testing (e.g., static and dynamic axial compression, subsidence, expulsion).

The text does not contain any information about an AI-powered diagnostic device or a study involving human readers, ground truth establishment by experts, or any data provenance related to AI model testing. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI device, as the provided document is not relevant to that type of information.

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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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