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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:

1. A table of acceptance criteria and the reported device performance: Not present. The document states bench testing was not required.
2. Sample size used for the test set and the data provenance: Not applicable, as no new performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device is a physical medical implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. 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.

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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 sacroiliitis. 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 sacroiliac joint.

The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 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-6A1-4V ELI that conforms to the ASTM F136 standard.

The provided text is a 510(k) premarket notification for the SI-Cure Sacroiliac Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than on a clinical study to prove the device meets specific performance criteria through empirical patient data or diagnostic accuracy.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment from a clinical or diagnostic performance study cannot be extracted from this document, as such a study was not performed or referenced for this submission.

The document explicitly states:

"Bench testing was not required in this submission because the system name change, the updates to the indications for use statement, and the additional implant sizes, which do not introduce a new worst case, do not affect the safety and effectiveness of the device to require performance testing."

This indicates that the submission relies on the existing performance data and substantial equivalence of the predicate devices.

Ask a specific question about this device