Search Results

The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VeriFixx™ SBI is single use, gamma sterilized device that is surgically implanted into the intramedullary canal of the bones in the toe to create a fusion and provides stability and maintain the alignment of bone during the healing process. The device is a solid, non-threaded implant that has a superior surface protrusion known as the dorsal fin, which is intended to maintain alignment of the joint during the healing process.

The provided text describes a medical device, the VeriFixx™ Small Bone Implant, and its 510(k) summary for FDA clearance. However, it does not contain information about software or AI, nor does it provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI-based device's performance.

The document is purely a regulatory submission for a physical medical implant, focusing on its substantial equivalence to a predicate device based on bench testing.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device