(55 days)
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint ● disruptions
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.
The provided text is a 510(k) summary for the Xenix Medical Sacroiliac Fixation System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.
However, the document does not describe the acceptance criteria and the study that proves the device meets those acceptance criteria in the context of an AI/ML medical device. The information requested in the prompt, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy), sample size for test sets (along with data provenance), expert ground truth establishment, MRMC studies, or standalone algorithm performance, is completely absent from this document.
The performance testing described here is for mechanical properties, sterilization, bacterial endotoxin, and navigation instrument accuracy, which are typical for traditional hardware medical devices like orthopedic fixation systems, not AI/ML algorithms.
Therefore, I cannot provide the requested information based on the given input. The device referred to in the document is a physical implant and surgical instrumentation system, not an AI/ML-driven diagnostic or therapeutic device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.