(55 days)
Synthes Combination Clamp and Dynamization Clip – MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:
- Stabilization of soft tissue injuries and open or closed fractures;
- Polytrauma;
- Vertically stable pelvic fractures as a treatment adjunct for vertically unstable pelvic fractures;
- Arthrodesis and osteotomies with soft tissue problems;
- Failures of total joints;
- Neutralization of fractures stabilized with limited internal fixation;
- Non-unions;
- Intraoperative reduction/stabilization tool to assist with indirect reduction;
- Unilateral rectilinear bone segment transport or leg lengthening.
Synthes Large Combination Clamp and Dynamization Clip-MR Safe are components of an external fixation frame that forms a construct intended to treat long bone and pelvic fractures. The Dynamization Clip is an accessory to the clamp that allows dynamization during bone healing. These devices are intended for use in the MR environment. Frame components accept Synthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws in diameters of 4 - 6 mm.
The provided text is a 510(k) summary for the "Synthes Large Combination Clamp and Dynamization Clip – MR Safe." It describes the device's intended use, materials, and classification, and states that it has been determined to be substantially equivalent to a predicate device.
However, the provided text DOES NOT contain information about acceptance criteria, device performance testing (including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), or the training set for any AI/ML model.
This document is a regulatory submission for a physical medical device (an external fixation clamp) and not an AI/ML-driven device. Therefore, the questions related to AI/ML model performance, ground truth, and training/test set details are not applicable to the content provided.
The text focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. For such devices, performance is typically assessed through aspects like:
- Material compatibility: Ensuring the selected materials are biocompatible and suitable for medical use.
- Mechanical strength/durability: Testing the physical integrity and load-bearing capacity of the device under simulated physiological conditions.
- Sterilization validation: Confirming that the device can be effectively sterilized without degradation.
- MR Safety evaluation: Demonstrating that the device is safe for use in magnetic resonance environments (which is explicitly stated in the device name "MR Safe").
Without the specific test reports or performance data that would have been submitted alongside this 510(k) summary, it's impossible to describe the acceptance criteria and study details requested in the prompt.
§ 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.