(207 days)
The OrthoFundamentals TRELLIST™ SI Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:
Sacroiliac joint disruptions
Degenerative sacroiliitis
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The TRELLIS™ SI Joint Fusion System is a multiple component system consisting of sterile single use accessory instruments and sterile individually packaged screws of various lengths and diameters. The screws are designed to compress and stabilize the sacroiliac joint during the fusion process. They are self-tapping and are designed with a porous mid-shaft region to allow bone to grow onto and into its surface. The cannulated screws have axial fenestrations that allow bone through growth and packing with autograft bone or allograft material. The screws are designed to promote bony fusion onto and into the implant through the macro-surface topography which is generated through EBM additive manufacturing. The fenestration geometry harvests autograft during insertion which helps create an environment for bony in-growth and on-growth.
The provided text describes the regulatory clearance (510(k) submission) for the TRELLIS™ SI Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than proving device performance through clinical studies with acceptance criteria in the context of diagnostic accuracy or clinical outcomes.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this document as it's a submission for a medical device (implantable screw system), not a diagnostic algorithm or AI software.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense of a diagnostic or AI study (e.g., sensitivity, specificity thresholds). Instead, it lists various bench tests performed to demonstrate substantial equivalence to predicate devices. The "performance" is reported as "Substantially Equivalent" or "Pass" compared to the predicate or established standards.
| Test | Finding |
|---|---|
| Screw Pull-Out Force Testing | Substantially Equivalent |
| Insertion and Removal Torque Testing | Pass |
| Torsion Properties Testing | Substantially Equivalent |
| Static and Fatigue Bend Testing | Substantially Equivalent |
| Package Seal Strength Verification | Pass |
| Surface Characterization | Substantially Equivalent |
| Biocompatibility Justification | Pass |
| Component Testing Plan and Justification for Test Coupon Location | Pass |
| Porous Surface Lattice Abrasion Resistance | Pass |
| Porous Surface Lattice Stereological Evaluation | Pass |
| Porous Surface Lattice Mechanical Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as there was no clinical or animal testing reported in this 510(k) summary. The "test set" refers to the mechanical/physical properties of the device components themselves, not patient data. The provenance of the data is from laboratory bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth, in the context of diagnostic or AI studies, refers to definitive diagnoses or classifications. For a medical device like this, "ground truth" would be the engineering specifications and performance values established through validated testing methods. The "experts" involved are likely engineers performing and evaluating the bench tests against established standards.
4. Adjudication Method
This information is not applicable. Adjudication is relevant for reviewing conflicting expert opinions in diagnostic studies, which is not the nature of this submission. The "adjudication" for bench tests would be the interpretation of test results against relevant ASTM standards or internal specifications by qualified engineers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. No MRMC study was performed as this is a physical medical device, not a diagnostic AI or imaging interpretation system designed to assist human readers.
6. Standalone (Algorithm Only) Performance
This information is not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the bench tests effectively consisted of:
- Engineering specifications and standards: Performance requirements derived from relevant ASTM standards (e.g., for mechanical strength, biocompatibility).
- Predicate device performance: The performance characteristics of the legally marketed predicate devices against which the TRELLISTM system was compared to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device submission. This is a physical device, not an AI model requiring a training dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device submission.
§ 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.