(87 days)
The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The technological characteristics of the Small Fragment Locking Plating System are the same as the predicate devices including design and material.
The provided text is a 510(k) summary for the "Small Fragment Locking Plating System." This document is a regulatory submission for a medical device and, as such, does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include detailed performance metrics or clinical study results in the format requested.
510(k) submissions primarily focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. The document states:
- "The technological characteristics of the Small Fragment Locking Plating System are the same as the predicate devices including design and material."
- "The Small Fragment Locking Plating System is substantially equivalent to the currently marketed Synthes and DePuy devices. No new issues of safety or efficacy have been raised."
Therefore, I cannot extract the information requested for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from this document. These types of details would typically be found in engineering validation reports, biocompatibility testing reports, or potentially clinical study data if "new issues of safety or efficacy" were raised, which is stated not to be the case here.
§ 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.