(87 days)
The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
Genesys Spine's Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micromotion in order to enable bony fusion. All screws and anchors are cannulated and self-tapping; they are offered with different diameters (up to 13.5mm), lengths (up to 70mm), and styles to accommodate variations in patient anatomy and surgeon preference. Fusion across the graft space can be aided by the addition of bone graft material to the lumen of each screw; fenestration in each screw allow for direct allograft apposition across the sacroiliac joint. Dual thread screws and fully threaded screws provide joint compression by utilizing a compressive thread pattern. Optional Washers are included to aid in conforming to patient anatomy and to help distribute the load onto a larger area. All implants are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI). The delivery system uses guide pins for accurate surgical placement into pre-drilled bone. All implants will be provided non-sterile and are intended for single use only.
This document, K191748, is a 510(k) Premarket Notification from Genesys Spine for their Sacroiliac Joint Fusion System. As such, it does not contain details of clinical studies, acceptance criteria, or ground truth establishment typically associated with AI/ML-driven medical devices.
Medical devices cleared through the 510(k) pathway, especially those like bone fixation fasteners, are primarily evaluated based on equivalence to legally marketed predicate devices through non-clinical performance evaluations (mechanical testing), rather than human clinical trials or complex algorithms requiring extensive performance studies with acceptance criteria for sensitivity, specificity, etc.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance: This document does not present such a table. The acceptance criteria for this device are implied by its substantial equivalence to predicate devices, meaning it must meet similar mechanical and material properties.
- Sample size used for the test set and data provenance: Non-clinical mechanical testing does not involve human subjects or "data provenance" in the clinical sense. Test "samples" would refer to the number of devices tested, but specific numbers are not provided, only the standards used (e.g., ASTM F2193-18a).
- Number of experts used to establish ground truth: Not applicable for a mechanical device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an image-based diagnostic or AI-assisted device.
- Standalone (algorithm only) performance: There is no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as there's no machine learning model.
- How the ground truth for the training set was established: Not applicable.
What the document does provide in terms of performance evaluation:
The document states that non-clinical testing was performed on "worst-case devices" and "demonstrated substantially equivalent performance to the predicate systems." The mechanical tests performed are listed:
- Static Bending Strength (ASTM F2193-18a)
- Fatigue Bending Strength (ASTM F2193-18a)
- Torsional strength/breaking angle (ASTM F543-17)
- Insertion/removal torque (ASTM F543-17)
- Pullout force (ASTM F543-17)
The acceptance criteria for these tests would be defined by the specified ASTM standards and the performance of the predicate devices. The "reported device performance" is summarized by the statement that it "demonstrated substantially equivalent performance to the predicate systems," meaning it met or exceeded the performance benchmarks set by the predicates under these test conditions. However, specific numerical results or detailed pass/fail thresholds are not included in this summary.
§ 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.