(100 days)
This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.
The provided text is a 510(k) summary for the Biomet Microfixation Adkins Strut. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment for a new device performance study is not available in the provided text.
The 510(k) summary explicitly states:
"Substantial Equivalence Biomet Microfixation considers the Adkins Struts equivalent to the American V. Mueller Adkins Strut (Pre-amendment device)."
This indicates that the submission relies on the pre-amendment status of the predicate device, implying that extensive new device performance studies to establish specific acceptance criteria were not required in the same way they would be for a novel device. The FDA's letter (Page 1 of the filing) reiterates this by stating they have determined the device is "substantially equivalent...to legally marketed predicate devices."
As a result, I cannot populate the table or answer the specific questions about device performance against acceptance criteria based on this document.
§ 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.