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The ARx® SAI Implant System is intended for sacroiliac joint fusion for the following conditions:
· Sacrolliac joint dysfunction and degenerative sacrollitis include conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization of the sacroiliac ioint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to Arx® Spinal System, the ARx SAI Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed

• by patient history and radiographic studies.
• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal Stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis)
• · Spinal tumor
• Pseudarthrosis
• · Failed previous fusion

The ARx® SAI Implant System consists of an assortment of implants in various lengths and diameters, and associated instruments sets for both Open and minimally invasive [MIS] approaches. The bone screw, head, and taper lock are assembled during manufacturing to create the ARx® SAI Implant System screw assembly component. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory, and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, ARx® SAI Implant System can be placed into the S1 pedicle. It is designed for connection to the Arx Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods. The ARx® SAI Implant System implant components are made from Titanium alloy (Ti- 6A1-4V ELI) as described by ASTM Fl36.

This document is a 510(k) premarket notification for a medical device called the ARx® SAI Implant System. It presents information to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no study described that involves acceptance criteria, device performance metrics, or any of the detailed questions related to AI/algorithm performance (sample size, ground truth, expert involvement, MRMC study, standalone performance).

The document focuses on the mechanical performance of the implant system and its substantial equivalence to existing devices, not on the performance of a diagnostic or assistive algorithm.

The "Performance Data" section states:
"An engineering analysis to compare technological features and finite element analysis for cantilever bending and torque to failure were performed between the ARx® SAI Implant System and primary predicate device. Screw pullout and driving torque testing per ASTM F543 were performed. All performance data demonstrates substantial equivalence to the predicate devices."

This indicates that mechanical tests were conducted, and the results demonstrated substantial equivalence. However, specific acceptance criteria values and reported performance values are not detailed in this extract. The study design described is a comparison of mechanical properties with predicate devices, not a clinical study involving human or image-based data for an AI or diagnostic tool.

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