(30 days)
The SI Joint Fusion System is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SI Fusion System consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone to create fixation. The system includes 4.0 mm and 7.0 mm diameter fusion rods, which range in length from 30 mm to 70 mm.
The SI-Bone's SI Fusion System is a medical device. Based on the provided 510(k) summary, the device is a modification to a previously cleared SI Joint Fusion System, and its purpose is for fracture fixation of large bones and large bone fragments of the pelvis, including sacroiliac joint disruptions and degenerative sacroiliitis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (overall) | Performance data demonstrates that the SI Joint Fusion System is as safe and effective as previously cleared SI Joint Fusion System. The minor differences in technological characteristics (inclusion of 4.0 mm diameter rods) do not raise new questions of safety or effectiveness. |
| Fixation of SI Joint (Specific to functionality) | Results from Finite Element Analysis (FEA) demonstrate that the SI Fusion System is substantially equivalent with respect to fixation of the SI joint compared to its predicate. |
| Material (implicitly, due to substantial equivalence claim) | Metallic (titanium), porous plasma spray coated rods. Inherits material safety and biocompatibility from the predicate device through substantial equivalence. |
| Dimensions (for new rod sizes) | The system includes 4.0 mm and 7.0 mm diameter fusion rods, ranging in length from 30 mm to 70 mm. The 4.0 mm rods are new compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The primary performance data presented is derived from a Finite Element Analysis (FEA), which is a computational simulation, not a study performed on a physical test set or human/animal subjects with a sample size.
- Data Provenance: Not applicable for FEA. It's a computational analysis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The performance data is from a Finite Element Analysis (FEA), which does not involve establishing ground truth through expert review in the clinical sense. The "ground truth" for an FEA would be the accuracy of the computational model itself and its parameters, which are validated against engineering principles and known material properties. The document does not specify details of this validation.
4. Adjudication Method for the Test Set
- Not applicable, as there was no test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data is based on a Finite Element Analysis (FEA), which is a non-clinical, computational study, not a clinical study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system. Its performance is inherent to its mechanical design and material properties. The FEA is a simulation of the device's mechanical performance, not a standalone algorithm in the context of AI.
7. The Type of Ground Truth Used
- The primary "ground truth" for the performance data (FEA) would be the established principles of biomechanics, material science, and engineering validation methods for computational models. The document does not explicitly state how this "ground truth" of the FEA model itself was validated or established. The outcome of the FEA demonstrated substantial equivalence to the predicate device, implying that the predicate's performance served as the comparative benchmark.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning system that requires training data or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this 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.