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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 anterior/anterolateral 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® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

The Stryker Spine Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone 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 are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.

This submission is intended to address a line extension to Xia " 4.5 Spinal System. The line extension includes:

• A new size dual staple component in both a rostral and a caudal configuration.
• A new polyaxial cross connector in sizes small, medium, large, and extra large, and
• A new longitudinal rod-to-rod connector to join a Ø 4.5 mm rod from the Xia" 4.5 ■ Spinal System to a Ø 6.0 mm rod from the Xia® Spinal System (K013688, K984251), DIAPASON The Spinal System (K951725), and OPUS "M Spinal System (K993402 & K030369).

This submission describes a line extension to an existing spinal system, not a device that would typically involve acceptance criteria and a study to prove performance in the way an AI/ML diagnostic device would.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies) are not applicable to this type of device (a spinal fixation system).

Here's an interpretation based on the provided document and the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A): This is a mechanical device, not typically evaluated with "test sets" of data in the sense of AI/ML or diagnostic devices. The "test set" would consist of samples of the components for mechanical testing.
• Provenance: This information is not detailed in the summary, but given it's a medical device manufacturer, it would typically be internal testing performed by Stryker Spine.

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

• Not Applicable (N/A): No "ground truth" in the diagnostic or AI sense is established for this type of device. Performance is determined by engineering specifications and mechanical testing standards.

4. Adjudication method for the test set

• Not Applicable (N/A): Adjudication methods are relevant for subjective evaluations, typically in diagnostic or AI studies. For mechanical testing, results are typically quantitative and compared against predefined engineering standards.

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 (N/A): This is for a spinal fixation system, not an AI/ML diagnostic and does not involve human readers or AI assistance.

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

• Not Applicable (N/A): This is for a spinal fixation system, not an AI/ML algorithm.

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

• Not Applicable (N/A): For mechanical devices like this, the "ground truth" is defined by engineering specifications, material properties, and performance standards established through industry-recognized mechanical testing (e.g., fatigue, strength, torsional stability). The regulatory body (FDA) assesses if these tests demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable (N/A): No "training set" in the AI/ML sense is used for this device.

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

• Not Applicable (N/A): No "ground truth" or "training set" as understood in AI/ML is relevant for this device.

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The Xia Spinal System and Xia 4.5 Spinal System are 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 6 mm diameter rods from the DIAPASONTM Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

The Xia® Spinal System contains the same Stainless Steel and Titanium alloy components described in the predicate Xia® Spinal System submission cited above. The Xia® 4.5 Spinal System contains the same Titanium alloy components described in the predicate Xia® 4.5 Spinal System submission cited above. This submission adds an additional indication statement, but no new components.

The provided document is a 510(k) summary for the Stryker Spine Xia® and Xia® 4.5 Spinal Systems. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested in your prompt.

Therefore, I cannot provide the requested information from this document. The document primarily discusses:

• Device Description: The Xia® and Xia® 4.5 Spinal Systems contain Stainless Steel and Titanium alloy components and are adding an additional indication statement.
• Intended Use: Anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: Stryker Spine Xia® Spinal System (K053115), Stryker Spine Xia® 4.5 Spinal System (K052761), Medtronic Sofamor Danek's CD Horizon System (K032033).
• Technological Characteristics: Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed.
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

This type of submission typically relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) to demonstrate equivalence rather than a human-in-the-loop clinical study with experts establishing ground truth, as would be common for AI/diagnostic devices.

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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, nonpedicle 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 XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.

The Stryker Spine Xia" 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone 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 are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.

This submission is intended to address a line extension to Xia" 4.5 Spinal System. The line extension includes a new range of Titanium alloy connectors.

This submission is a 510(k) premarket notification for a line extension to an existing spinal system. It does not describe a study involving an AI/ML device or its performance characteristics. Instead, it focuses on demonstrating substantial equivalence to a predicate device for a modified medical implant. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable to this document.

The document describes the:

• Identification of the device and sponsor.
• Description of the device modification: A line extension including a new range of titanium alloy connectors for the Xia® 4.5 Spinal System.
• Intended Use: Specifies the indications for both posterior noncervical pedicle fixation and anterolateral and posterior, non-cervical, non-pedicle fixation, for skeletally mature patients only.
• Statement of Technological Comparison: Asserts that the new components share the same intended use, material, and basic design concepts as the predicate device (Xia® 4.5 Spinal System, K050461). It also states that "Mechanical testing also demonstrated comparable mechanical properties to the predicate device." This is the only mention of "testing" and it refers to mechanical properties, not clinical or algorithmic performance.
• FDA's substantial equivalence determination letter: Confirming the device is substantially equivalent to legally marketed predicate devices.

In summary, there is no clinical study or AI/ML device performance evaluation presented in this document. The submission is for a modification to a spinal implant and relies on demonstrating substantial equivalence through material, design, intended use, and mechanical properties.

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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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