(442 days)
Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Adkins-Fonkalsrud Pectus Excavatum Strut, which confirms the device's substantial equivalence to a legally marketed predicate device. It outlines regulatory information but does not include any performance study details as requested.
§ 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.