(484 days)
The SternaFuse® Fixation System is indicated for use in the stabilization of fractures of the anterior chest wall, including stemal fixation following sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.
The SternaFuse® Fixation System implants are composed of 316 LVM implant quality stainless steel plates, links, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in two diameters, 3.0mm and 3.3mm, and lengths of 10mm, 13mm, and 16mm. Multiple plates may be used in one anterior chest wall repair. Variable Assemblies can be configured, and the Links angled for optimum fixation. Implants are designed with centralized saddles to aid in intra-operative contouring, to facilitate cutting during postoperative emergent re-entry, and to provide a location for stainless steel wire.
The implants are individually packaged and sterilized, allowing the surgeon to customize the desired implants for the specific needs of the patient. All implants are provided sterile with a five-year shelf-life. The implants should never be reused under any circumstance.
This document is a 510(k) premarket notification for a medical device called the SternaFuse® Fixation System. It details the device's indications for use, description, comparison to predicate devices, and performance data.
From the provided text, there is no information about a study that describes acceptance criteria or performance for an AI/CADeX device. The document focuses on a physical medical device (bone fixation system) and its mechanical, material, and sterility testing, not on software or AI performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/CADeX device, nor can I answer questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/test set details for such a device from this document.
The "Performance Data" section (Section 9) exclusively discusses:
- Biocompatibility (Section 9.1): Assessed according to ISO 10993-1 for 316LVM Stainless Steel.
- Pyrogenicity/Endotoxin Testing (Section 9.2): Performed to meet acceptance criteria of
§ 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.