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The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacrollitis and sacroiliac joint disruptions, to augment immobilization of the sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, nonacute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The Entasis 3D Dual-Lead Sacroiliac Implant System consists of additive and machined dual-lead sacroiliac screws and optional washers to aid in load bearing and conformity to patient anatomy. The Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured from additive titanium alloy (Ti-6Al-4V) per ASTM F3001 or machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. These screws are available in lengths from 30 mm to 110 mm and diameters of Ø7 mm to Ø14.5 mm.

The provided text describes a 510(k) premarket notification for a medical device called the "Entasis 3D Dual-Lead Sacroiliac Implant System." This document is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared predicate devices.

Crucially, the provided text does not contain any information about the acceptance criteria, study methodologies, or performance results related to an AI/ML algorithm or software as a medical device (SaMD). It describes a physical implant system and its mechanical testing for structural integrity.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets them, as the input material is irrelevant to such a request.

This document focuses on:

• Device Description: A sacroiliac implant system made of titanium alloy for joint fusion.
• Intended Use: Sacroiliac joint fusion for various conditions including degenerative sacroiliitis, joint disruptions, sacropelvic fixation augmentation, and fractures.
• Technological Characteristics: Comparison to predicate devices, highlighting similarities in indications, materials, structural support, surgical approach, sizes, and design features.
• Performance Data: Non-clinical (mechanical) testing of the implant system itself (Static Torsion, Driving Torsion, Pullout, Static & Dynamic Cantilever Bending).
• Conclusion: The device is substantially equivalent to predicate devices based on technological characteristics and mechanical performance.

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