(118 days)
The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
The CheckMate™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture . loop intended to provide a traction force required to achieve compression between bone segments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.
The provided document is a 510(k) summary for the CheckMate™ Small Bone Fusion System. It states the intended use, device description, and substantial equivalency to predicate devices. However, this document does not contain information about studies to prove specific acceptance criteria for device performance based on clinical outcomes, AI performance metrics, or ground truth establishment relevant to the questions asked.
Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or training set ground truth is not present in the provided text.
The document focuses on regulatory approval through substantial equivalence, which relies on demonstrating similarity to already cleared devices based on intended use, materials, and design, typically supported by comparative mechanical testing (e.g., four-point bending tests) and dimensional analyses, rather than clinical efficacy studies.
§ 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.