(70 days)
The INTEGRA Total Wrist Fusion System is indicated for use in patients with:
- Posttraumatic arthritis of the joints of the wrist .
- Rheumatoid wrist deformities requiring restoration ●
- Complex carpal instability .
- Post-septic arthritis of the wrist .
- Severe unremitting wrist pain related to motion .
- Brachial plexus nerve palsies .
- Tumor resection .
- Spastic deformation .
- Pain and/or loss of function due to osteoarthritis
- Revision of failed partial wrist fusions
The INTEGRA Total Wrist Fusion System offers rigid fixation capabilities for the wrist joint of patients utilizing a plate and screw system. The system includes the implant, consisting of the plate and screws, as well as associated instrumentation.
The provided text is a 510(k) summary for the INTEGRA™ Total Wrist Fusion System. It states that the device is substantially equivalent to existing predicate devices. However, the document does not contain any information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The section "Testing and Test Results" on page 1 only vaguely states: "Tests have been performed to verify the mechanical suitability of the device. Results demonstrate that the mechanical properties of the INTEGRA Total Wrist Fusion System are substantially equivalent to the predicate devices." This statement is a summary conclusion and lacks any specific details required to answer the questions about acceptance criteria and study design.
Therefore, I cannot provide the requested table and information based on the given document. The document describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical suitability but does not elaborate on specific acceptance criteria or the methodology of the study conducted.
§ 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.