(28 days)
The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint.
The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 mm, Ø10.5 mm, and Ø11 mm diameter and various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw head for load distribution. The screws are made from titanium alloy Ti-6AL-4V ELI per ASTM F136. The purpose of this submission is to add headless screws with additional screw size options to the previously cleared system.
This document is a 510(k) premarket notification for a medical device called the "SI-Cure Sacroiliac Joint Fusion System." It describes the device, its indications for use, and its equivalence to predicate devices. However, it explicitly states that bench testing was not required for this submission because the changes (adding headless screws and new size options) do not introduce a new worst-case scenario for mechanical performance compared to already cleared implants.
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria. It primarily focuses on demonstrating substantial equivalence based on technological characteristics and the premise that the modifications do not negatively impact mechanical performance beyond what has already been established for the predicate device.
To directly answer your request based on the provided text, the following information is either not applicable or not present:
- A table of acceptance criteria and the reported device performance: Not present. The document states bench testing was not required.
- Sample size used for the test set and the data provenance: Not applicable, as no new performance testing was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 device is a physical medical implant, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The conclusion of the submission is that "The overall technology characteristics and mechanical performance evaluation lead to the conclusion that subject SI-Cure Sacroiliac Fusion Joint System is substantially equivalent to the predicate device." This equivalence is based on:
- Similar or same indications for use
- Material of manufacture
- Structural support mechanism
- Sizes and features (with the new additions not creating a new worst-case)
- Sterilization
- Manufacturing and biocompatibility
- Mechanical performance (evaluated against existing predicate data, not new testing for this submission)
In summary, this 510(k) submission relies on prior demonstrations of safety and effectiveness for the predicate devices and argues that the current modifications do not warrant new performance testing.
§ 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.