(101 days)
The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.
The Aesculap Resorbable Pin is a small orthopedic fixation pin made from a copolymer material (Poly-L,DL -Lactide Co70/30) that is absorbed into the body over time.
The provided text is for a 510(k) summary for the Aesculap Resorbable Pin. This document indicates that no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Arthrex Meniscal Dart System and Bionx Smart Nail).
Therefore, there is no performance data or study described in the provided text that establishes acceptance criteria or proves the device meets specific performance criteria. The clearance is based on the claim of substantial equivalence to existing devices, implying that the safety and effectiveness are considered comparable based on the established profile of those predicate devices.
As a result, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided 510(k) summary for this particular device.
§ 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.