(141 days)
Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
The Biomet Microfixation Sternal Closure System (sometimes abbreviated SL) of plates, including the SternaLock Blu system, is made up of plates of varying shapes currently including, but not limited to, X plates, box plates, straight plates, and L plates. The plates have at least one cuttable cross section, but not more than 4 of these sections when they are intended to cross a non-transverse fracture or sternotomy. There are plates without cuttable cross sections to assist in the fixation of transverse fractures. The plates accept screws with a diameter of 2.4mm and 2.7mm. Self-drilling screws have a maximum length of 20mm. The tip of the selfdrilling screw is designed so that a predrilled hole is not required, but may be used.
The provided document is a 510(k) summary for a medical device (Biomet Microfixation Sternal Closure System) and does not contain information about acceptance criteria and a study proving a device meets them.
Instead, it's a regulatory document demonstrating substantial equivalence to previously cleared devices. It describes the device, its intended use, materials, possible risks, and details related to its design, which are similar to existing devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or ground truth establishment.
The document primarily focuses on establishing similarity to predicate devices rather than presenting the results of a performance study against specific acceptance criteria.
§ 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.