(87 days)
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.
| Acceptance Criteria | Reported Device Performance (Not explicitly stated, only "substantially equivalent") |
|---|---|
| Static and Dynamic Cantilever Testing per ASTM F2193 | Met substantial equivalence to predicate |
| Post-Fatigue Sleeve Dissociation Testing | Met substantial equivalence to predicate |
| Static Torsion Testing per ASTM 543 | Met substantial equivalence to predicate |
| Static Axial Pull out Testing per ASTM 543 | Met substantial equivalence to predicate |
| Characterizing the Porous Surface Bedrock Granite Test (Static Shear, Shear Fatigue, Static Tensile, Abrasion Properties) | Met substantial equivalence to predicate |
| Construct Testing per ASTM F1717 (Static and Dynamic Compression Bending, Static Torsion) | Met substantial equivalence to predicate |
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.
§ 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.