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When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region.

When used as a Cervical Interbody Fusion device. NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

The NeoFuse Ti3D PLIF/TLIF/Cervical devices are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F136. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody. This document focuses on demonstrating substantial equivalence to predicate devices rather than the performance of a novel AI/software medical device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/software device's performance.
• A study proving a device meets AI/software performance acceptance criteria.
• Sample sizes for test sets in an AI/software context.
• Data provenance for AI/software data.
• Number of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
• Standalone (algorithm-only) performance studies for AI.
• Type of ground truth used for AI studies.
• Sample size for training sets for AI.
• Ground truth establishment for training sets for AI.

The information provided describes non-clinical testing performed on a physical intervertebral body fusion device to demonstrate its safety and effectiveness, specifically:

• Acceptance Criteria (for the physical device's mechanical properties): The document states that "FDA performance standards have been established" for the device, and the listed tests (Static/dynamic axial compression, torsion, shear, subsidence, expulsion) were performed to demonstrate safety based on "current industry standards." The conclusion is that the device "does not raise new issues of safety or efficacy compared to the predicates," implying it meets these established industry and FDA mechanical performance standards.
• Reported Device Performance: The document only states that "The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices." Specific numerical performance values (e.g., maximum force withstood, specific subsidence depth) are not reported in this summary.
• Sample sizes: Not specified for the mechanical tests, but implied to be sufficient for demonstrating substantial equivalence.
• Data provenance: Not applicable in the context of device mechanical testing.
• Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are not applicable as this is a review of a physical medical implant, not an AI/software device.
• Training Set/Ground Truth for training: Not applicable for a physical device.

In summary, the provided text is about a 510(k) submission for a physical intervertebral body fusion device and does not contain the information required to answer the prompt regarding AI/software device acceptance criteria and study details.

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