(287 days)
The SI-Bone 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. Their intended use is for fracturc fixation of large bones and large bone fragments of the pelvis for such conditions as sacroiliac joint disruptions and degenerative sacroiliitis. The system includes 7.0 mm fusion rods, which range in length from 30 mm to 70 mm.
The SI-Bone 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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance |
|---|---|
| Axial pullout resistance substantially similar to predicate devices | Bench-top testing demonstrated substantial similarity to predicate devices |
| Stability in dynamic cantilever bending substantially similar to predicate devices | Bench-top testing demonstrated substantial similarity to predicate devices |
| Fixation of SI joint substantially similar to predicate devices | Finite Element Analysis (FEA) and bench-top testing results support substantial similarity |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text for the bench-top testing. The text refers to "bench-top testing" and a "study" in general terms.
- Data Provenance: Not explicitly stated. The testing appears to be conducted by the company (SI-Bone, Inc.) and is likely proprietary. There is no mention of country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The performance data presented is based on engineering analyses and bench-top mechanical testing, not on human expert assessment of a test set. Therefore, no experts were used to establish ground truth in the traditional sense of clinical or image-based studies.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which is not the nature of the performance data described (FEA and bench-top biomechanical testing).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The performance data focuses on the mechanical properties and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used:
The ground truth for the performance assessment was based on:
- Engineering principles and models: For the Finite Element Analysis (FEA).
- Physical measurements and biomechanical testing standards: For the bench-top testing of axial pullout resistance and dynamic cantilever bending. The "ground truth" is essentially the established mechanical properties and performance of the predicate devices.
8. The sample size for the training set:
This information is not applicable. The SI-Bone SI Joint Fusion System is a hardware device (metallic rods); it is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for a hardware 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.