(17 days)
Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates consist of curved plates and straight plates that are contourable in three planes. The plates have a smooth, rounded profile. Plate holes are slightly oval, allowing 30 degrees of angulation in all directions. The 3.5 mm Low Profile Reconstruction Plate accepts Synthes 3.5 mm Cortex Screws and Synthes 3.5 mm Pelvic Screws.
I am sorry, but the provided text describes a medical device (Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate) and its regulatory clearance (510(k) summary). There is no information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance.
The document discusses:
- Sponsor, contact, device name, classification, and predicate device.
- Device description, intended use, and materials.
- Regulatory review process by the FDA for substantial equivalence to a predicate device.
- Indications for use statement for the surgical plate.
Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies because this information is not present in the provided text.
§ 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.