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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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The Innovasis® TxTiHA™ IBF 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 Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

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.

TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The 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 through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.

AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The 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 through-growth.

The provided text is a 510(k) summary from the FDA for two intervertebral body fusion devices, the TxTiHA™ IBF System and the AxTiHA™ Stand-Alone ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than presenting a clinical study or acceptance criteria in the typical sense for a new AI/medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially those related to clinical trials, AI, ground truth, and human reader performance) is not present in this document.

However, I can extract the information that is available:

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

The document does not provide a table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing:

The core "acceptance" for this type of device (a 510(k) submission) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Sample Size: Not applicable. The document describes non-clinical performance testing of the devices themselves (e.g., mechanical strength), not a clinical test set involving patient data or imaging. Therefore, concepts like sample size of patients, data provenance, retrospective/prospective studies, or country of origin are not mentioned.
• Data Provenance: The non-clinical tests likely occurred in a lab setting. The company is Innovasis, Inc. in Salt Lake City, Utah, USA.

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. This document does not describe a clinical study requiring human experts for ground truth establishment.

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

Not applicable. There is no test set in the clinical sense described here.

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. This is not an AI-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an AI device.

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

Not applicable. The "ground truth" for these physical devices is their compliance with specified ASTM standards and material properties, verified through non-clinical mechanical testing, rather than clinical outcomes or expert labels.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set described.

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