(122 days)
The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions: ·Sacrollac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6months. • To augment immobilization and stabilization of the sacroliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint When connected to the SeaSpine Mariner Pedicle Screw System, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • Degenerative disc disease (DDD) as defined by back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies · Spondylolisthesis ·Trauma (i.e., fracture or dislocation) ·Spinal stenosis · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) •Spinal tumor •Pseudarthrosis ·Failed previous fusion The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant System procedures, 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 the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.
The iFuse Bedrock Granite™ Implant System consists of implants of various lengths and diameters, and associated instruments sets (Open and MIS). The titanium (Ti-6AI-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to the SeaSpine Mariner Pedicle Screw System in both the SAI and the Iliac trajectories. It is designed for connection to the SeaSpine Mariner Pedicle Screw System via Ø5.5mm or Ø6.0mm titanium alloy or cobalt chrome spinal fixation rods.
This document describes the regulatory clearance of the iFuse Bedrock Granite™ Implant System. It does not describe an AI/ML medical device, and therefore the provided information does not include the details required to answer your specific questions regarding acceptance criteria and performance studies for such devices.
The document is a 510(k) summary for a medical implant system and its associated navigation instruments. It focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use and Indications for Use: The conditions the device treats and its purpose.
- Technological Characteristics: The design, materials (titanium), and how it functions.
- Manufacturing Methods: How it's produced.
- Principles of Operation: How it achieves its intended effect.
- Performance Data: Primarily biocompatibility and mechanical testing (e.g., bending, torsion, pullout, fatigue) to ensure the device is safe and performs as expected under physical stresses.
Therefore, I cannot provide the detailed information requested in your prompt (e.g., acceptance criteria for an AI model's performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) because this 510(k) summary does not pertain to an AI/ML device.
The document states: "Any differences between the iFuse Bedrock Granite Implant System and the predicate devices do not raise any different questions of safety or effectiveness, as demonstrated by the results of the verification and validation testing." The "performance data" section lists the types of tests done (Biocompatibility Testing and Mechanical Testing), which are standard for implantable hardware. There is no mention of algorithms, AI/ML, or image analysis performance metrics.
§ 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.