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Xpine Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• · 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
• · failed previous fusion

The Xpine Spinal Fixation System, Internal Fixation Device for Spinal Surgery, is comprised of: Pedicle Screw, Set Screw. Rod. and Cross Link. Various forms and sizes of these implants are available to consider the unique pathology of individual patients for purposes of stabilization, or corrective action through the application of force. Components are made of Ti6Al4V ELI, a titanium-based alloy, which complies with ASTM F136.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Xpine Spinal Fixation System," which is a Thoracolumbosacral Pedicle Screw System.

This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:

• Indications for Use Comparison: Showing that the new device has similar intended uses.
• Technological Comparison: Demonstrating that the materials, design, and other technological characteristics are substantially similar and do not raise new questions of safety or effectiveness.
• Bench Testing: Performing mechanical tests to ensure the device meets relevant ASTM standards and performs comparably to the predicate device.

The document explicitly states: "Clinical data is not applicable." This means there was no clinical study, human-in-the-loop study, or a study involving human readers and AI assistance performed for this device as part of this 510(k) submission.

Therefore, I cannot provide details on:

1. Acceptance criteria and reported device performance (in the context of AI/diagnostic accuracy). The acceptance criteria mentioned refer to mechanical bench test results (e.g., meeting or exceeding values from reference literature for spinal implant constructs), not diagnostic performance metrics like sensitivity or specificity.
2. Sample size, data provenance, ground truth establishment, or expert involvement for a diagnostic test set.
3. Adjudication method.
4. MRMC study and effect size.
5. Standalone (algorithm-only) performance.
6. Type of ground truth (beyond mechanical test standards).
7. Training set sample size or ground truth establishment for a training set.

The document is about a mechanical spinal fixation system, not a diagnostic AI/software device.

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