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The Herbert ™ Mini Bone Screw (2.5mm diameter, non- cannulated) and the Herbert ™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non- union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.

The Herbert/Whipple ® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

The Herbert ™ Cannulated Bone Screw System (4.5mm and 6.5mm diameter) are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.

The Herbert devices are cannulated and non-cannulated variable pitch screws that are headless, threaded at both ends and are made from Tivanium ® Ti-6Al-4V Alloy. Herbert screws are designed to provide rigid fixation for various fractures.

The supplied text does not describe an AI medical device, but rather a set of bone screws. Therefore, I cannot provide an answer to your request. The document discusses the Herbert/Whipple® Bone Screw System and related devices, focusing on their indications for use, design, and non-clinical performance data such as shelf life, biocompatibility, and mechanical performance. There is no mention of acceptance criteria or a study related to an AI device.

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