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The XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The XIA 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Stryker Spine Xia 4.5 Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients, particularly those with a smaller stature, as an adjunct to fusion. The Stryker Spine Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial screws, Blockers, Hooks, Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.

The provided document does not contain specific acceptance criteria or a detailed study report that would allow for a complete description of the acceptance criteria and a study proving device performance as requested.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criteria for the Xia 4.5 Spinal System were based on its mechanical properties being equivalent or superior to those of its predicate devices.

Detailed Study Information (Not Present in the Document):

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria, human reader studies, or ground truth establishment. Therefore, most of the requested information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not available in this document.

Here's why each specific point cannot be addressed:

• 2. Sample size used for the test set and the data provenance: Not mentioned. The "comparable mechanical properties" likely refer to bench testing, not a clinical test set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This level of detail is for clinical studies, which are not described here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a spinal fixation system, not an AI-driven diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" would be the established mechanical performance standards or previously validated mechanical properties of the predicate devices.
• 8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of what is available:

• Device: Xia 4.5 Spinal System
• Proof of Meeting Criteria: "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."
• Nature of Study: A substantial equivalence review based on mechanical (bench) testing, comparing the subject device to existing predicate devices. This is a standalone performance evaluation in the context of mechanical properties, not for an AI algorithm.
• Ground Truth for the study: The established mechanical properties of the predicate devices.
• Outcome: The FDA determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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