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The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and 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 DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA 4.5 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA 4.5 Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System consists of a variety of titanium Monoaxial & Polyaxial Bone Screws, Monoaxial & Polyaxial Reduction Screws, Hooks, Blockers, Rod Connectors, Dual Staples and Connectors. The existing components of the XIA 4.5 Spinal System were determined substantially equivalent through K050461 for class II indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, and K092605.

The expansion of indications for the XIA 4.5 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediation. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediation is not warranted.

This document (K121342) is a 510(k) premarket notification for the Stryker XIA® 4.5 Spinal System, seeking clearance for expanded indications, specifically for adolescent idiopathic scoliosis.

The acceptance criteria and study information indicate that the device's substantial equivalence relies on biomechanical testing and a clinical literature analysis, not on a clinical ground truth study as typically seen for AI/ML devices. Therefore, many of the requested fields are not applicable.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The submission relies on biomechanical testing and literature review rather than a clinical test set in the context of an AI/ML device.
• Data Provenance: Not applicable for a clinical test set. Biomechanical testing would have been conducted in a lab environment.

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

• Number of Experts: Not applicable. Ground truth from experts is not mentioned for this type of submission.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission.

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

• MRMC Study: No. This is a spinal implant, not an AI/ML diagnostic or assistive device.

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

• Standalone Study: No. This product is a physical spinal implant, not an algorithm.

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

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established performance characteristics of the predicate devices and the relevant ASTM standards for spinal implants. For the clinical literature analysis, the literature itself serves as the basis for comparison. No clinical "ground truth" as in pathology or outcomes data from a prospective study of this device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

• Degenerative disc disease (DDD) (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 DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

This 510(k) is intended to introduce an extension to the existing XIA® 4.5 Spinal System. The proposed line extension includes the addition of titanium Screws (monoaxial, polyaxial and reduction) and rod-to-rod connectors.

This document describes a 510(k) premarket notification for a line extension of the XIA 4.5 Spinal System. It is not a study that proves a device meets acceptance criteria through clinical or AI performance evaluation. Instead, it demonstrates substantial equivalence to existing predicate devices based on material, design, and indications for use. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.

Here's why and what the document does provide:

1. Nature of the Submission: This is a "Special 510(k) Premarket Notification" for a line extension to an existing Class III spinal system. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive new clinical trials or performance studies involving algorithms.

2. Focus of the "Study": The document states: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This refers to bench testing and engineering analysis (e.g., mechanical strength, fatigue, material compatibility) to ensure the new components (titanium screws and rod-to-rod connectors) meet established performance standards for spinal fixation devices and are comparable to the predicate devices. It is not a clinical study involving patients, or an AI performance study.

Therefore, the following requested information is not present or applicable in this 510(k) submission:

• Table of acceptance criteria and reported device performance (in the context of clinical or AI performance): The "acceptance criteria" here are likely mechanical and material specifications met through engineering tests against regulatory guidance, not clinical outcome metrics.
• Sample size for the test set and data provenance: No clinical test set involving human subjects or AI algorithms is described.
• Number of experts used to establish ground truth and qualifications: Ground truth in the context of clinical or AI performance is not applicable here.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted or reported.
• Standalone (algorithm-only) performance: No AI algorithm is part of this device.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an engineering-focused 510(k).
• Sample size for the training set: No AI training set.
• How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

• Acceptance Criteria (Implied - Regulatory & Engineering): The devices are substantially equivalent to predicates, meaning they meet the same safety and performance profiles as those devices. This is demonstrated through adherence to FDA guidance for spinal system 510(k)s, which would involve mechanical testing standards (e.g., fatigue, static bending), material biocompatibility, and sterilization validation. The "Indications for Use" statement also acts as a boundary for acceptance.
• Study (Type of "Study" Performed): "Engineering analysis and testing" were performed. This is typically bench testing (in vitro mechanical tests) rather than human clinical trials. These tests ensure the new components perform equivalently to the predicate devices and meet relevant ISO or ASTM standards for spinal implants.

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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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