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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® 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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