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The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-L Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0 , 6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Special 510(k) submission is to gain clearance for the subject devices to be provided sterile via gamma radiation.

The provided text is a 510(k) summary for the Nexus Spine Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System. It states that the purpose of the Special 510(k) submission is to gain clearance for these devices to be provided sterile via gamma radiation, whereas the predicate devices were provided non-sterile. The document explicitly states:

"The subject components are identical in indications, sizing and geometry, technological characteristics, and materials to the predicates. The only difference between the subject device and predicate device is that the subject device is provided sterile via gamma radiation and the predicate device is provided nonsterile. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness."

And under "Performance Testing":

"There is no change to the intended use, indication for use, materials, geometry, or dimensions to the Stable-L Standalone Lumbar Interbody System or Stable-C Interbody System. There is no mechanical performance testing included in this submission. Sterilization validation, packaging validations, and shelf life validation have all been performed to support the gamma radiation sterilization change."

Based on this, the acceptance criteria and study proving the device meets the acceptance criteria are not related to the clinical performance or diagnostic accuracy of an AI/ML-driven device, but rather to the sterility and packaging integrity of a medical implant after a change in sterilization method.

Therefore, I cannot provide the information requested in points 1-9 of your prompt, as it pertains to AI/ML device validation (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.). This document describes a medical device, but its 510(k) submission focuses on a sterilization method change, not an AI/ML component.

If you are looking for an example of an AI/ML device clearance document, this specific text will not provide the details you're seeking regarding AI/ML acceptance criteria and performance studies.

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