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The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) 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.

Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.

The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are manufactured from titanium alloy per ASTM F136.

Based on the provided text, the document is a 510(k) clearance letter for a medical device (IdentiTi™ II Interbody System), not a study report proving the device meets specific acceptance criteria based on AI/software performance. Therefore, the information required for a study proving acceptance criteria for a device involving AI or complex algorithm performance is not present in this document.

The document discusses the substantial equivalence of the IdentiTi™ II Interbody System to existing predicate devices based on:

• Intended Use & Indications for Use: Spinal fusion procedures.
• Design, Function, and Technology: Specifically mentions additive manufacturing from titanium powder, roughened surface features, microporous lattice structure, and an anti-migration plate.
• Non-clinical Performance Data: Lists various ASTM standards for static and dynamic mechanical testing, gravimetric analysis, particle analysis, static push-out, stereological analysis, static screw push-out, and bacterial endotoxin testing. These are standard tests for intervertebral body fusion devices, not for AI or software performance.

Since this document is entirely focused on a traditional hardware medical device and its mechanical/biocompatibility testing, it lacks all the requested information pertaining to AI/software acceptance criteria and a study proving those criteria.

Therefore, I cannot fill out the requested table or answer the specific questions about AI/software performance, ground truth, expert adjudication, or MRMC studies.

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