(66 days)
The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula. olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
The Merete BLP™ Small Fragment Locking Bone Plate System consists of anatomically shaped U-oblique plates, right or left in the length of 33, 35 and 37 mm and 3.0 mm locking screws. The system is available in titanium (ASTM F-136), Locking plates/screws incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction.
This is a 510(k) premarket notification for a medical device (Merete BLP™ Small Fragment Locking Bone Plate System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific evaluations (like MRMC studies, standalone performance, training sets) is not applicable or present in the provided document.
A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for AI algorithms. The document confirms that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, materials, and technological characteristics.
Therefore, I cannot populate the requested tables and sections as the information is not relevant to this type of regulatory submission.
§ 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.