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The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:

· Sacroiliac 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 peripartum period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in 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 screws with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, 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 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

When connected to compatible pedicle screws with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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 various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6A1-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant 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 pedicle screw fixation systems in both the SAI and the iliac trajectories. Additionally, iFuse Bedrock Granite can be placed into the S1 pedicle. The device is designed for connection to commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm titanium alloy or cobalt chrome alloy spinal fixation rods.

This FDA 510(k) summary document for the iFuse Bedrock Granite® Implant System does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the document primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical benchtop testing rather than clinical performance or AI/software-related performance metrics.

Here's a breakdown of what can be extracted and what is missing:

The device is a medical implant system and instruments, not an AI or software-only device. Therefore, questions related to AI performance, such as sample sizes for test/training sets, ground truth establishment for AI, expert numbers for ground truth, adjudication methods, and MRMC studies, are not applicable in this context.

Information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several performance tests according to ASTM standards. It states: "The test results demonstrate that the device is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., minimum load, maximum deformation) and the numerical results (reported device performance) for each test are not provided in this summary. It only lists the types of tests performed.

Information that is missing or not applicable based on the document:

• 2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are benchtop mechanical tests, not clinical studies with patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical bench testing is typically defined by engineering specifications and material properties, not expert clinical consensus from images.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical implant, not an AI diagnostic or assistive device. The navigation instruments are mentioned, but no performance data is provided for them, let alone an MRMC study comparing human performance with and without AI assistance for these instruments.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device against which the subject device's performance is compared for substantial equivalence. No clinical ground truth types are mentioned.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) pertains to a physical medical device (implant system) and its mechanical performance, rather than an AI-driven software device. Therefore, many of the requested details related to AI performance metrics, clinical studies, and expert-established ground truths are not present or relevant in this document. The "study" proving acceptance criteria is a series of mechanical benchtop tests demonstrating substantial equivalence to a predicate device.

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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.

Ask a specific question about this device