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The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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); 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 account for the unique pathology of individual patients.

The Iliad™ Spinal Fixation and Adjustable Bridge 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.

The Kora™ Spinal Fixation and Adjustable Bridge 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.

The subject of this 510(k) is the addition of Z-Rods to the spinal systems.

The provided document describes the Medyssey USA, Inc. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems, specifically focusing on the addition of "Z-Rods" to these systems. The document is a 510(k) premarket notification summary to the FDA, indicating a request for clearance based on substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that mechanical testing was performed according to ASTM F2193-14. The acceptance criteria would be the standards set forth by this ASTM standard for spinal implant constructs. The reported device performance is that the "Results demonstrated substantial equivalence compared to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Mechanical testing per ASTM F2193-14 was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is a mechanical performance study, not a clinical study involving experts or ground truth establishment in a diagnostic context. Therefore, this question is not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as this is a mechanical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable, as this is a mechanical performance study.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

Not applicable, as this is a mechanical performance study of a physical spinal fixation system, not a software algorithm.

7. Type of Ground Truth Used:

For this mechanical performance study, the "ground truth" would be the established engineering and biomechanical properties and performance requirements outlined in the ASTM F2193-14 standard.

8. Sample Size for the Training Set:

Not applicable, as this is a mechanical performance study. There is no "training set" in the context of device mechanical testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is a mechanical performance study.

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