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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordoric interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure Titanium (ASTM F67). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

This document is a 510(k) Premarket Notification from Xenco Medical, LLC. for their CancelleX Porous Titanium Lumbar Interbody Device. It outlines the regulatory submission process and the data provided to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a study comparing device performance to human readers with or without AI assistance. It focuses on a medical implant (an intervertebral body fusion device) and demonstrates its substantial equivalence through biocompatibility testing and bench testing, as typically required for physical medical devices of this type.

Therefore, I cannot provide the information requested in your prompt because it is designed for studies of AI/ML-driven diagnostic or assistive devices, and this document pertains to a physical medical implant.

The document specifically states:

• "Animal performance data was not required to determine substantial equivalence."
• "Clinical performance data was not required to determine substantial equivalence."

It concludes that "Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent."

Since the information you requested (acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, and training set details for AI/ML) is not present in this document, I cannot generate a response that fulfills those specific points based on the provided text.

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