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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Zenius 146 Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.

The provided text describes a 510(k) summary for a spinal system and its modification, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or even extensive non-clinical testing beyond basic mechanical and sterilization validation.

This document specifically states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system." The purpose of this submission was for the clearance of the redesign of the custom sterilization trays, not for assessing the clinical performance or efficacy of the spinal system itself beyond its substantial equivalence to the previously cleared predicate.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text, with clear limitations:

1. Table of acceptance criteria and the reported device performance:

Important Note: The document focuses on demonstrating substantial equivalence to a previously cleared device, particularly for a modification to sterilization trays. It does not present new performance data for the implant itself beyond the scope of that modification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Mechanical Testing: Not specified for this submission, as the mechanical tests (ASTM F 1717-04) were already performed for the predicate device, and the current submission primarily concerned sterilization trays. For the sterilization validation, the sample size and provenance are not detailed in this summary; it just states it was "satisfactorily performed."
• Clinical Data: No clinical tests were conducted for either the subject system or the predicate system (as stated in the document).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical tests were performed, and thus no expert ground truth was established from clinical data for this submission. The "ground truth" for mechanical testing would be the ASTM standards, and for sterilization, the AAMI guidelines.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no clinical tests were performed and no human adjudication of results is mentioned for the non-clinical tests.

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:

• No MRMC comparative effectiveness study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a mechanical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For mechanical properties: ASTM F 1717-04 standards.
• For material properties: ASTM F 136 standard for titanium alloy.
• For sterility: AAMI ST77 and AAMI ST79 guidelines.
• No clinical ground truth (expert consensus, pathology, outcomes data) was used or generated for this specific submission because no clinical studies were performed.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established:

• Not applicable. This is a mechanical device, not a machine learning algorithm.

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