Search Results

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.

Ask a specific question about this device