(30 days)
The OsteoCentric Cannulated Fasteners and Nuts is indicated for use in bone reconstruction, osteotomy, arthrodesis (joint fusion), and fixation of fractures and ligaments:
The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric 3.5mm Cannulated Screws are intended for the arthrodesis or fixation of fractures and fragments of hand, midfoot, and forefoot bones, extremity osteochondritis dissecans lesions, and for extremity ligament fixation.
The OsteoCentric 4.5mm to 8.0mm Cannulated Screws are intended for fixation of long bone fractures and fragments. Iong bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, pediatric femoral neck fractures, intercondylar femur fractures, fixation of the pelvis and pelvic joints, and arthrodesis (e.g., ankle, subtalar).
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for reduction and stabilization of fractures or inter-osseous distances (e.g. syndesmosis injuries).
The OsteoCentric Technologies Cannulated Fasteners and Nuts come in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The fasteners are provided non- sterile and are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. Instrumentation is also provided non-sterile to properly insert the OsteoCentric Technologies Cannulated Fasteners and Nuts. All instrumentation is intended to be reusable, with the exception of the guidewires are provided non-sterile and are intended for single-use only.
The provided text is a 510(k) summary from the FDA for a medical device (cannulated fasteners and nuts). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria related to a software or AI based medical device.
The document primarily focuses on the physical characteristics, materials, and mechanical applications of bone fixation fasteners and nuts, asserting that the new device is "physically and technologically identical" to a previously cleared predicate device. There is no mention of an algorithm, AI, or any data-driven performance study typically associated with the type of questions asked (e.g., sample size, expert ground truth, MRMC studies, standalone performance).
Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details for an AI/software device based on the provided text. The document is for a hardware medical device, not a software one.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.