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The Xia 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 6 mm diameter rods from the DIAPASON™ Spinal System and OPUSTM Spinal System arc 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.

This 510(k) is intended to introduce an extension to the existing Xia Titanium Spinal System and Xia Stainless Steel Spinal System that includes long arm bone screws and hooks.

The provided document is a 510(k) Premarket Notification for a line extension to the Xia Titanium Spinal System and Stainless Steel Spinal System. It does not describe a study involving acceptance criteria for device performance in the context of an AI/human-in-the-loop system. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

The document primarily states:

• Acceptance Criteria/Proof of Device Meeting Criteria: "Engineering analysis to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System Long Arm Bone Screws and Long Arm Hooks." This indicates that compliance with an FDA guidance document, likely involving mechanical and material testing, served as the "proof," rather than clinical performance metrics in the context of the questions asked.

The entire request is framed around the evaluation of an AI-driven device, which is not what this document addresses. This is a traditional medical device (spinal fixation system) 510(k) submission.

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