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Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Xenco Medical CancelleX Cervical Interbody System 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. Spacers are manufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14). The system also includes instruments manufactured using 6061 T6 Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTM F899). All system implants and instruments are provided sterile packaged and are intended for single use.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the Xenco Medical CancelleX Cervical Interbody System. It is not a study report for an AI/ML medical device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in this document.

The document focuses on demonstrating substantial equivalence of a physical medical device (an intervertebral body fusion device) to existing predicate devices. It discusses:

• Device Description: Generally box-shaped with surface teeth, a central channel for autogenous bone, available in various shapes and sizes, manufactured from Titanium Alloy.
• Indications for Use: Spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease, implanted via an open, anterior approach, packed with autogenous bone, used with supplemental fixation.
• Technological Comparison: Similar design and sizing to predicates, but 3D printed from titanium with porous latticed areas, similar to an additional predicate.
• Non-Clinical Test Summary & Conclusions: Benchtop mechanical testing was performed according to ASTM standards (F2077 for static/dynamic axial compression, compression shear, and torsion; F2267 for subsidence), and expulsion testing per lab protocol. The conclusion states that the subject device has at least equivalent mechanical strength as the predicates.
• Clinical Testing: The document explicitly states, "Clinical testing was not applicable for this submission."

Since this document pertains to a physical implantable device and not an AI/ML software device, none of the specific questions regarding AI/ML device performance, acceptance criteria, or study methodologies can be answered from the provided text.

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