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The Innovasis AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

The AxTiHA Stand-Alone ALIF System is for Anterior Lumbar Interbody Fusion (ALIF). The IBF implants are an additive manufactured device comprised of Ti-6Al-4V (ELI) per ASTM F3001 and Hydroxyapatite (HA) and are available in multiple size options to facilitate a more precise anatomical fit. The IBF implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell® Technology structure provide increased volume for autograft loading and bone throughgrowth. The IBF devices include integrated fixation by way of three converging bone screws and optional screw anti-backout locking clips manufactured from Ti-6AI-4V (ELI) per ASTM F136.

This document is an FDA 510(k) clearance letter for a medical device called the "AxTiHA® Stand-Alone ALIF System." It does not contain information about an AI/ML powered medical device, therefore, a detailed answer based on your request cannot be provided.

The document discusses a physical medical device used in spinal fusion surgery (intervertebral body fusion device), not a software or AI-based diagnostic/therapeutic tool. The performance data mentioned (ASTM F2077 for Dynamic Axial Compression and Dynamic Compression Shear, and bone screw pushout) are related to the mechanical properties and stability of the physical implant, not to the accuracy or performance of an AI model in interpreting medical images or data.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, ground truth establishment for AI model training or testing.
• Expert consensus, adjudication methods, or MRMC studies for AI model evaluation.

The document confirms the device's substantial equivalence to a predicate device based on mechanical testing, which is appropriate for a physical implant.

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