(90 days)
The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:
- rheumatoid wrist deformities requiring restoration of alignment and stability
- carpal instabilities
- severe unremitting wrist pain related to motion of the carpus
- other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.
Carpal Engaging Wrist Fusion Plate
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Terray Carpal Engaging Wrist Fusion Plate). It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs typically associated with AI/ML device evaluations.
Therefore, I cannot extract the requested information to fill in the table and answer the questions about a study on device performance.
§ 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.