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The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The INNESIS PEEK implant incorporates ridges on both its superior and inférior surfaces to help eliminate migration. A graft space help facilitate bony integration once implanted. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V).

The provided document is a 510(k) summary for the INNESIS PEEK CAGE, an intervertebral body fusion device. It primarily details the device's information, indications for use, and substantial equivalence to predicate devices, along with performance testing conducted. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical or diagnostic performance, as might be expected for an AI/ML medical device.

The "Performance Testing" section refers to benchtop engineering tests performed according to ASTM standards for intervertebral body fusion devices, focusing on mechanical properties such as:

• ASTM F2077-11: "Test Methods for Intervertebral Body Fusion Devices."
• ASTM F2267-04: "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
• ASTM Draft Standard F-04.25.02.02: "Static Push-out Test Method for Intervertebral Body Fusion Devices," Draft #2 - August 29, 2000.

These tests evaluate the physical integrity, load-bearing capacity, and resistance to migration of the implant itself, not its performance in a diagnostic or AI-assisted scenario.

Therefore, the requested information elements related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.

The document describes the acceptance criteria in terms of meeting the specifications defined by the ASTM standards for structural and mechanical performance of the implant. The "study" proving this involves the execution of these specific ASTM test methods.

Given the nature of the device (a PEEK cage implant) and the provided 510(k) summary, I cannot fill out the requested table or answer the questions related to AI/ML device performance. This document pertains to a physical medical implant, not a diagnostic or AI-powered technology.

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