(99 days)
The iFuse Bedrock Granite® Implant System is intended for sacroiliac joint fusion for the following conditions:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac 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 compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys the iFuse Bedrock Grante 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 with degeneration 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
Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.
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 (for both open and minimally invasive [MIS] approaches). The titanium (Ti-6Al-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 compatible pedicle screw fixation systems in both the SAI and the Iliac trajectories. It is designed for connection to compatible commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm diameter circular titanium alloy or cobalt chrome alloy spinal fixation rods. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.
The provided text describes a 510(k) premarket notification for the iFuse Bedrock Granite® Implant System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about a study based on AI/ML models or human-in-the-loop performance, nor does it refer to acceptance criteria related to such studies.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance related to an AI/ML study.
- Sample size used for the test set or its provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily discusses mechanical testing to demonstrate the device's compatibility and structural integrity with existing spinal fixation systems. The "Performance Data" section (Page 6) states:
- "SI-BONE performed the following mechanical testing of the connection of the Bedrock Granite tulip to commercially available representative rods."
- "Static Axial Grip per ASTM F1798 (axial gripping capacity)"
- "Static Axial Torsion Grip per ASTM F1798 (torsional gripping capacity)"
- "Dynamic Axial Compression per ASTM F1717 (dynamic compression bending)"
- "Testing was performed on a range of rod diameters and manufacturing methods to demonstrate compatibility with the iFuse Bedrock Granite® Implant System."
- "The test results demonstrate that the device is substantially equivalent to the legally marketed predicate device and does not raise different questions of safety and effectiveness compared to the predicate device."
This indicates that the "study" proving the device meets acceptance criteria is a series of mechanical tests according to specific ASTM standards, not a clinical or AI/ML performance study. The acceptance criteria would be the pass/fail thresholds defined by those ASTM standards for the mechanical properties tested (e.g., specific load capacities, bending resistance). The "reported device performance" would be the measured values from these mechanical tests.
§ 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.