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The Butrex® Lumbar Buttress Plating System is intervertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The Butrex® Lumbar Buttress Plating System consists of a variety of shapes and sizes of bone plates and screws. The Butrex plates contain two sockets for screw placement on one end and a buttressing surface on the other end. The system is intended for anterior screw fixation to the L1 to S1 spine. The components are manufactured from titanium alloy (Ti 6Al 4V ELI). The titanium conforms with ASTM F136, Standard Specification Wrouqht Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surqical Implant Applications (UNS R56401). A separate intervertebral fixation construct, such as posterior pedicle screws, must be used for proper stabilization to be achieved.

The system does not contain software/firmware.

This FDA 510(k) K170530 is for a spinal intervertebral body fixation orthosis, the Butrex® Lumbar Buttress Plating System. This device is a physical medical device, not an AI/ML powered device. As such, the standard acceptance criteria, study methodologies, and performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment with expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence based on technological characteristics and design.

Therefore, I cannot provide the requested information for acceptance criteria and study details as they pertain to AI/ML device evaluations. The document focuses on material, design, and indications for use equivalence for a traditional implantable medical device.

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