(112 days)
The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
The Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
The provided text is a 510(k) summary for the First Ray Internal Bone Staple System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.
The document states:
"Clinical data were not needed to support the safety and effectiveness of the subject device."
"The Internal Bone Staple System performance was characterized through static pullout testing in bone analog material and static and fatigue four-point bend testing per ASTM F564-10 (2015) with a side-by-side comparison to the predicate device."
Therefore, I cannot provide the requested information for an AI/ML powered device based on the given text. The device is a physical bone staple system, and its evaluation relies on mechanical testing against predicate devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.