(166 days)
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:
- Primary total hip arthroplasty. .
- Revision total hip arthroplasty. .
- . Any procedure using anterolateral or lateral approaches.
The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
The purpose of this Traditional 510(k) is to add MR safety information to the labeling and update the information within the labeling, including the package insert for the subject Smith & Nephew ACCORD™ Cable System. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the materials, sterilization, or the manufacturing processes of the previously cleared devices due tothe addition of MR labeling for this subject 510(k). The Smith & Nephew ACCORD™ Cable System consists of the following previously cleared devices:
This document does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification for the Smith & Nephew ACCORD™ Cable System, focusing on adding MR safety information to the labeling and updating existing information.
The key points from the provided text are:
- Device: Smith & Nephew ACCORD™ Cable System.
- Purpose of Submission: To add MR safety information to the labeling and update other labeling information.
- No Changes to Core Device: The technological characteristics, function, materials, packaging, sterilization, and manufacturing processes of the device remain unchanged from previous clearances.
- Predicate Devices: The device is deemed substantially equivalent to two previously cleared Smith & Nephew devices: the Bone Plate System (K993106) and the Orthopaedic Cabling System (K031162).
- Performance Data: Performance data is mentioned only in the context of Magnetic Resonance Imaging (MRI) compatibility testing, conducted according to specific ASTM standards and FDA guidance.
- Engineering Analysis: Engineering analysis and dynamic tensile strength testing were performed to demonstrate substantial equivalent mechanical performance of the plates and cables to the predicate devices.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text. The document is a regulatory filing for an update, not a clinical study report or a detailed performance and validation study.
§ 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.