(109 days)
The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.
The SIJFuse™ Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy (Ti-6A1-4V Eli). Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. Solid and Fenestrated screws have a cannulated core. Fenestrated screws allow packing of allograft or autograft material.
This document is a 510(k) premarket notification for the "SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System". It describes the device, its intended use, and presents data to demonstrate substantial equivalence to predicate devices. However, this is NOT a study describing acceptance criteria and device performance as typically understood for AI/software devices.
The information provided describes a medical device (implants), specifically screws for sacroiliac joint fusion, and is not an AI/Software as a Medical Device (SaMD). Therefore, the requested information categories (AI-specific acceptance criteria, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, AI ground truth, etc.) are not applicable to this document.
Instead, this document focuses on mechanical performance data to demonstrate the physical characteristics and safety of a hardware implant.
Here's the relevant information provided by the document regarding the device's performance and acceptance:
1. Table of Acceptance Criteria (or rather, performance data compared to predicates):
The document states: "The results of this non-clinical testing show that the strength of the SIJFuse™ Sacroiliac Joint Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
The following tests were performed:
| Acceptance Criteria (Test Modes) | Reported Device Performance (Conclusion) |
|---|---|
| Static three-point bending per ASTM F2193 | Sufficient for intended use; substantially equivalent to predicate devices. |
| Static axial pull out per ASTM F543 | Sufficient for intended use; substantially equivalent to predicate devices. |
| Dynamic three-point bending per ASTM F2193 | Sufficient for intended use; substantially equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of devices or tests, but "multiple tests" are implied by the nature of the standards. ASTM F2193 and F543 are standards that specify test methodologies, which would include guidelines on the number of samples required for statistically valid results. This document only states that the tests were performed.
- Data Provenance: The tests were non-clinical, meaning they were performed in a laboratory setting. No country of origin for data is specified beyond the company being US-based (Beverly, MA). It is not retrospective or prospective in the clinical sense, as it refers to engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles, not by expert medical interpretation.
4. Adjudication method for the test set:
- Not Applicable. Mechanical tests are adjudicated by meeting specified physical criteria outlined in the ASTM standards.
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 hardware implant, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware implant, not an algorithm.
7. The type of ground truth used:
- Mechanical Engineering Standards: The "ground truth" for this device's performance is compliance with established ASTM (American Society for Testing and Materials) standards for orthopedic implants (F2193 and F543) and demonstrable equivalence in mechanical properties to legally marketed predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a hardware implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
In summary, the provided document relates to a physical medical implant and its mechanical performance testing for FDA 510(k) clearance, not an AI or software device. The acceptance is based on demonstrating substantial equivalence in mechanical properties to already cleared devices, as proven by adherence to specific ASTM testing standards.
§ 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.