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The StaXx® Systems have the following indications:

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® XDL System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be used with autograft or allograft and supplemental spinal fixation.

The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The StaXx® Systems are composed of expandable implants and interlocking wafers, which are implanted through a delivery system that includes a Cartridge and a Surgical Gun. The Cartridge is inserted into the Surgical Gun which, when activated, sequentially delivers locking wafers from the Cartridge to the expandable implant. The wafers are designed to be inserted incrementally to form a stack and therefore attain the desired height.

The StaXx® XD and XDL Systems are vertebral body replacement devices intended for use in the thoracolumbar spine (TI-L5). They are composed of wafers that are stacked into an expandable implant to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markets for additional visualization under fluoroscopy. The StaXx® XD System is to be placed bilaterally while the StaXx® XDL System is to be placed unilaterally and both are to be used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® IB and IBL Systems are intervertebral body fusion devices composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The StaXx® IB implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate while the StaXx® IBL implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers.

The provided text is a 510(k) Summary for the StaXx® System, specifically focusing on clearance for a new Surgical Gun. This type of submission is for medical devices and primarily demonstrates substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria against a set of acceptance criteria in the way AI/software devices often do.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving a device meets those criteria in the context of an AI/software evaluation.

Here's a breakdown of why this information is not present and what is included instead:

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

• Not present. This document discusses "Performance Data" in section 8, stating that "non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices." However, it does not provide a table of acceptance criteria or specific reported performance metrics. Substantial equivalence in this context means proving the new device is as safe and effective as a legally marketed predicate device, not necessarily meeting a predefined numerical performance target.

2. Sample size used for the test set and the data provenance:

• Not present. The document mentions "Simulated Use Testing," "Insertion Testing," and "Cadaveric Testing" but does not detail sample sizes for these tests or data provenance. These are physical and mechanical tests demonstrating the device's functionality and safety, not statistical performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not present. This is not relevant for the type of device (spinal fusion system and surgical gun) and the type of submission (510(k) for substantial equivalence). Ground truth establishment by experts is typically relevant for diagnostic or AI-powered devices where human expert interpretation is the standard for comparison.

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

• Not present. See point 3.

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 present. This is specific to AI-assisted diagnostic or interpretation devices and is not applicable to a spinal fusion system and surgical gun.

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

• Not present. See point 5.

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

• Not present. See point 3.

8. The sample size for the training set:

• Not present. Training sets are relevant for AI/machine learning models. This document describes a physical medical device.

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

• Not present. See point 8.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (spinal fusion system and surgical gun) based on mechanical and functional testing, not a detailed performance study for an AI/software device against specific acceptance criteria.

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