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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 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 imited 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 through-growth. The IBF devices include integrated fixation by way of three converging bone screws and optional screw anti-backout locking clips manufactured from Ti-6Al-4V (ELI) per ASTM F136. Reusable instruments to support the ALIF surgery are provided with the implants in sterilization travs.

The provided FDA 510(k) clearance letter for the AxTiHA® Stand-Alone ALIF System does not contain information related to a study proving the device meets specific acceptance criteria in the context of AI/software performance.

The document details the clearance of a medical device implant (an intervertebral body fusion device) based on substantial equivalence to predicate devices, primarily considering its mechanical and material properties, and intended use.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth for AI/software evaluation cannot be extracted from this document.

The document states: "Engineering analysis of the subject device indicates that additional verification testing is not required to demonstrate substantial equivalence. Previous evaluations and performance testing (e.g., design verification and validation) performed on the predicate devices apply to the subject devices." This implies the submission focused on the physical characteristics and prior testing of similar devices, rather than a novel AI/software component requiring performance studies with human readers or standalone algorithm evaluations.

Based on the provided text, here's what can be inferred or explicitly stated, and what cannot:

Inferences from the Provided Document:

• Device Type: The AxTiHA® Stand-Alone ALIF System is an intervertebral body fusion device (an implant), not an AI/software medical device.
• Clearance Basis: Substantial equivalence to predicate devices (K212967 and K160605) based on indications for use, intended use, design, technology, and performance, primarily through engineering analysis and prior performance testing of predicates.
• No mention of AI/Software Performance: There is no indication or mention of any AI component, software algorithm, or diagnostic capabilities that would necessitate the types of performance studies (e.g., MRMC, standalone algorithm performance, expert ground truth establishment for image interpretation) you've inquired about.

Responding to Your Specific Questions Based on the Provided Text:

Since the document describes an implantable device and not an AI/software component, most of your questions are not applicable or cannot be answered.

1. A table of acceptance criteria and the reported device performance

   • Not Applicable. The document does not describe specific performance metrics for an AI/software component. For the physical implant, the "acceptance criteria" are generally met through demonstration of substantial equivalence via engineering analysis and previous testing on predicate devices, rather than a specific performance table in this document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. No test set for AI/software performance is mentioned. The clearance relies on substantial equivalence and engineering analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. No ground truth establishment for AI/software performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. No adjudication for AI/software performance is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. No MRMC study mentioned, as there is no AI assistance component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable. No standalone algorithm performance study mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. No ground truth for AI/software performance is mentioned. The ground truth for the physical device's safety and effectiveness would be based on established engineering principles, biocompatibility testing (likely referenced from predicate devices), and clinical performance of predicate devices.

8. The sample size for the training set

   • Not Applicable. No training set for an AI model is mentioned.

9. How the ground truth for the training set was established

   • Not Applicable. No training set for an AI model is mentioned.

In summary, the provided FDA 510(k) clearance letter pertains to a an implantable intervertebral body fusion device and provides no information related to the performance of an AI/software component. Therefore, the questions regarding acceptance criteria and study details for AI/software performance cannot be answered from this specific document.

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