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When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the JAVA Spinal Fixation System is also 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after development of a solid fusion mass. The system includes screws, rods, and connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

This document, K031265, describes the Spine Next SHIRAZ JAVA Spinal Fixation System. However, it does not contain the information needed to fill out the table regarding acceptance criteria and device performance as it pertains to AI/ML or diagnostic performance. This submission is for a traditional medical device (spinal fixation system), not a software as a medical device (SaMD) or an AI-powered diagnostic tool. Therefore, the requested information on AI/ML-related performance metrics, such as sample size, ground truth, expert adjudication, or MRMC studies, is not applicable or available in this document.

The document primarily focuses on:

• Device Description and Materials: The system includes screws, rods, and connectors made from Titanium Alloy (Ti6A4V).
• Indications for Use: Treatment of severe spondylolisthesis and various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine as an adjunct to fusion.
• Performance Data: Biomechanical testing was performed in accordance with ASTM F1717 and ASTM F1798. These are standards for mechanical properties of spinal implant systems, not for diagnostic accuracy or algorithmic performance.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices (Moss Miami K021880).

Therefore, I cannot provide the requested information for acceptance criteria and study proving AI device meets acceptance criteria, as this device is a physical spinal fixation system and not an AI-driven one.

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