(269 days)
Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.
The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies related to its AI performance. The document is a 510(k) premarket notification for a medical device called "TDM Plate and Screw Systems," which are metallic bone fixation appliances.
The document discusses:
- The device's trade name, regulation, and product codes.
- Its intended use (internal bone fixation for fractures, fusions, osteotomies, and non-unions in various parts of the body).
- The materials it is constructed from (Titanium alloy or pure Titanium).
- A comparison to predicate devices for substantial equivalence.
- Performance testing according to ASTM standards for metallic bone plates and screws.
However, it explicitly states: "Clinical data was not needed for this device." This indicates that no clinical studies, and therefore no studies evaluating AI performance or human reader improvement with AI, were conducted or presented in this 510(k) submission.
Therefore, I cannot provide answers to your specific questions regarding acceptance criteria, reported device performance (in the context of AI), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details 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.