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The iFuse-TORQ Implant System is indicated for:
· Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis
· Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments. iFuse-TORQ implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ implants, that are available in various lengths and diameters, allow for packing of autograft and allograft materials.

The provided text describes the 510(k) premarket notification for the iFuse-TORQ® Implant System, primarily focusing on its substantial equivalence to predicate devices and the expansion of its indications for use.

Crucially, the document does not contain information about acceptance criteria for an AI/ML-based device, nor does it describe a study proving such a device meets acceptance criteria. The iFuse-TORQ® Implant System is a medical implant (a smooth or threaded metallic bone fixation fastener), and the performance data presented relates to mechanical testing (axial pullout, torsional strength, insertion, and removal torque) as per ASTM F543, which are standard for orthopedic implants, not for AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document describes a traditional medical device clearance, not an AI/ML device clearance.

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