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The SOLACE Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliac joint disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SOLACE Sacroiliac Fixation System is also indicated for fracture fixation of acute, and nontraumatic fractures involving the sacroiliac joint.

The SOLACE Sacroiliac Fixation System Navigation Instruments are intended to be used with the SOLACE Sacrolliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The SOLACE Sacroiliac Fixation System consists of 3D printed medical grate Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The SOLACE implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

This document is a 510(k) summary for the SOLACE Sacroiliac Fixation System, a medical device for sacroiliac joint fusion and fracture fixation. It does not contain information about software or AI. Therefore, I cannot extract information related to acceptance criteria, study details, human-in-the-loop performance, or training/test set specifics for an AI/software device.

The document discusses the substantial equivalence of the device to previously cleared predicate devices, focusing on the addition of nano claims related to the implant's surface. The studies mentioned are primarily related to assessing the nano-surface features and their in vitro biological responses, not related to an AI/software's performance.

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