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The Medyssey Co, Ltd. Zenius Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft 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 Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

All implantable components are manufactured from Ti6Al4V ELI per ASTM F136 and wrought Co-Cr-Mo alloy per ASTM F1537. The subject of this submission is the addition of variable rods to the Zenius™ System.

This document is a 510(k) premarket notification clearance letter from the FDA for the Zenius Spinal System. It does not contain information about the performance of a device based on a study with acceptance criteria, human readers, or ground truth.

Specifically, there is no information in the provided text to address the following points in your request:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes 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 the effect size of human readers' improvement with AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses the substantial equivalence of modifications (addition of variable rods) to an existing device (Zenius Spinal System) to its predicate device based on performance testing related to ASTM F1717. This likely refers to mechanical and fatigue testing of the device components, not a study involving human readers or AI performance on patient data.

To clarify, the document states: "A rationale related to ASTM F1717 testing is provided showing the subject variable rod to be substantially equivalent to the predicate rods cleared in K131878." ASTM F1717 is a standard test method for both static and fatigue evaluation of pedicle screw systems. This indicates benchmark engineering performance, not clinical performance or AI algorithm performance.

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