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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 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 various screws, connectors and a hook.

This document is a 510(k) premarket notification for a medical device called the Stryker Spine XIA 3 Spinal System - Line Extension. It details the regulatory approval process and describes the device's intended use and technological characteristics. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving those criteria are met for an AI-powered medical device.

The provided text focuses on:

• Regulatory classification and approval: It states the device is substantially equivalent to existing predicate devices.
• Device description: It describes the Stryker Spine XIA 3 Spinal System as a spinal fixation system, its components, and its intended use for various spinal conditions in non-cervical regions.
• Predicate devices: It lists other Stryker Spine systems and a Moss Miami System as predicates.
• Technological characteristics summary: It mentions "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed." This statement refers to performance testing but does not provide the details of such tests, acceptance criteria, or specific results, nor does it refer to an AI device.

Therefore, I cannot extract the following information from the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is for a traditional medical device (spinal system hardware), not an AI-powered diagnostic or predictive device, which is typically what would require the detailed performance study information you are asking for.

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