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The Threshold Pedicular Fixation System and Palisade Pedicular Fixation System are intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis; trauma, (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Threshold Pedicular Fixation System consists of titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The provided document is a 510(k) premarket notification summary for the Spineology Threshold Pedicular Fixation System and Palisade Pedicular Fixation System. It describes the devices and their intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to the device's function or clinical outcomes.

The purpose of this 510(k) submission is to obtain clearance for the addition of a hydroxyapatite (HA) coating to existing pedicle screws. The core argument for substantial equivalence is that the HA-coated screws are fundamentally the same as the predicate devices, with the coating being a minor change.

Here's a breakdown of the requested information based on the document, noting where information is absent:

1. Table of acceptance criteria and the reported device performance:
   The document states: "Testing was not required to support this change. Spineology's risk analysis is sufficient to demonstrate the substantial equivalence of the HA-coated Threshold and Palisade pedicle screws to the predicate devices."
   Therefore, there are no specific acceptance criteria or reported device performance metrics for the device's functional performance or clinical outcomes presented in this document. The submission relies on substantial equivalence to predicate devices, which means their performance characteristics are considered similar to devices already cleared for market.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   As no performance testing was required or reported, there is no test set sample size or data provenance mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable, as no test set requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no test set requiring adjudication is described.

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. The device is a pedicle fixation system, not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a pedicle fixation system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no study requiring ground truth is described.

8. The sample size for the training set:
   Not applicable, as this is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI/machine learning device.

In summary, this 510(k) submission for the Spineology Threshold and Palisade Pedicular Fixation Systems (with HA coating) relies on the demonstration of substantial equivalence to legally marketed predicate devices, rather than on new performance testing to meet predefined acceptance criteria. The change is considered minor (addition of HA coating), and no new clinical or non-clinical performance studies were presented as part of this particular submission to prove specific performance metrics.

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