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The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with supplemental fixation.

The Kahtnu (previously Axis Orthopaedics) Chena-C Spacer System is consists of a variety of footprints and heights of cervical interbody spacer implants to assist in interbody fusion. The previously cleared Axis Chena Cervical PEEK Spacer System (K181140) implant components are fabricated from medical implant grade Polyetheretherketone and tantalum per ASTM F2026-17 and ASTM F560-17. The purpose of this Special 510(k) submission is to add titanium alloy (ASTM F136) cervical cages to the Chena-C Spacer System.

This document is a 510(k) summary for a medical device (CHENA-C Spacer System) but does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/algorithm-based devices.

The filing is for an intervertebral body fusion device, which is a physical implant, not an AI or algorithm-based diagnostic or therapeutic device. The "Performance Testing" section explicitly states that mechanical testing was performed on a predicate device and that the current subject device was evaluated to show "no new worst case is presented compared to the predicate devices. Therefore, no testing is required." This refers to mechanical and material safety and performance for a physical implant, not an AI model's performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/algorithm-based device from this document. The requested information points (1-9) are specific to the evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical device.

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