(70 days)
The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.
The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.
I am sorry, but the provided text only contains an FDA 510(k) summary for the "Precimed Hip Screw System" and related correspondence. This type of document is for a medical device (an implantable screw system), not an AI or software-based device that would have performance acceptance criteria, a test set, expert ground truth, or an MRMC study.
Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods as these are not relevant to this type of device and are not present in the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
§ 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.