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The Stryker Spine XIA 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• 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 Ø5.5 mm titanium and Vitallium rods from the Stryker Spine Radius® Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA® 3 Spinal System.

This 510(k) is intended to introduce an extension to the existing Xia 3 Spinal System. The proposed line extension includes the addition of titanium Uniplanar Screws, titanium Uniplanar Reduction Screws, and use of the Stryker Spine Radius Ø5.5 mm Vitallium® rod with the Xia® 3 Spinal System.

The provided text is for a Special 510(k) Premarket Notification for a spinal system (Xia 3 Spinal System – Line Extension), which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering analysis and performance testing for mechanical properties and biocompatibility, not clinical studies or AI/software performance evaluations.

Therefore, the specific information requested in your prompt (acceptance criteria for a device's performance often related to AI/software, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not typically applicable or found in this type of 510(k) submission for a physical medical implant.

The document does state:

• Study performed: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the Stryker Spine Xia 3 Spinal System."

However, it does not provide the specific details about:

1. Acceptance criteria and reported device performance (in a table): The document only generally states that testing was completed for compliance.
2. Sample sizes used for the test set and data provenance: Not applicable, as this refers to engineering tests, not a clinical data test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study or effect size of AI improvement: Not applicable, as this is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of clinical expert consensus. For engineering testing, the "ground truth" would be established mechanical properties or design specifications.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a "line extension" for an existing spinal fixation system. The "study" mentioned refers to engineering tests and analysis to ensure the new components meet established mechanical and material safety standards as per FDA guidance for spinal systems. It does not involve performance evaluation in the context of AI or diagnostic accuracy, which is what most of your questions pertain to.

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