(83 days)
The Smith & Nephew Bone Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations 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.
Smith & Nephew Bone Plates, Bone Screws, and Accessories like the predicate devices, include various sizes of implants to accommodate the individual requirements of patient anatomy.
This document is a 510(k) summary for the Smith & Nephew Bone Plate System. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) pathway focuses on demonstrating that the new device has the same intended use and similar technological characteristics as an existing, cleared device, and does not raise new questions of safety or effectiveness.
Here's why the requested information isn't present and what the document does provide:
- Acceptance Criteria and Reported Device Performance: This type of information is typically found in pre-market approval (PMA) applications or de novo submissions, which require clinical data. A 510(k) summary focuses on comparing the new device to a predicate device.
- Sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established: All of these points relate to a clinical study designed to test the performance of a device against specific metrics. Since this is a 510(k) summary, such a study is not part of the submission process unless the FDA specifically requests it to address new questions of safety or effectiveness, which is not indicated here.
What the document does provide is:
- Device Name: Smith & Nephew Bone Plate System
- Submitter Information: Smith & Nephew, Inc., Orthopaedic Division
- Intended Use: For pelvic, small, and long bone fracture fixation in adult or pediatric patients, including specific bones like 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.
- Predicate Devices: Richards Bone Plates and Bone Screws (Smith & Nephew), Osteo* Bone Plates and Bone Screws (Smith & Nephew), Titanium Plates (Synthes), Basic Screw Set (Synthes), ECT Plates and Screws (Zimmer), TiMAX™ Large Fragment System (DePuy), TiMAX™ Bone Screws (DePuy).
- Technological Characteristics: Stated as similar to legally marketed predicate devices, manufactured from similar or like materials, and indicated for similar uses.
- Regulatory Classification: Class II, Product Codes HRS (Plate) and HWC (Screw), Panel: Orthopaedics/87.
- FDA Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
In summary, this document is a regulatory filing for substantial equivalence, not a clinical study report with performance metrics.
§ 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.