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The SI-LOK™ Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The SI-LOK™ Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac ioint fusion and to provide fixation of large bones and large bone fragments of the pelvis. The cannulated partially threaded or fully threaded screws contain a preassembled contouring washer, and are offered in various diameters and lengths to accommodate patient anatomy. Optional screws may be used for supplemental screw fixation. The SI-LOK™ Sacroiliac Joint Fixation System screws and pre-assembled contouring washers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.

This document describes the SI-LOK™ Sacroiliac Joint Fixation System, a medical device, and the basis for its clearance, which is substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, many of the requested fields are not applicable to this type of device clearance. This submission does not involve an AI device or a diagnostic algorithm, but rather a mechanical fixation system.

Here's an analysis of the provided text with respect to your request:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The tests are mechanical, likely conducted in a lab setting rather than involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a mechanical device. "Ground truth" in the context of expert review of images or clinical outcomes is not relevant here. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured according to established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As this is mechanical testing, there is no adjudication of expert opinions.

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

• No. An MRMC study is not mentioned as this is a mechanical fixation system, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a mechanical fixation system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable / Mechanical Standards. For mechanical testing, the "ground truth" would be objective physical measurements against established engineering and material science standards (e.g., ASTM standards for titanium alloy properties, defined force limits for bending, pull-out, etc.). The document states the screws are made from titanium alloy "as specified in ASTM F136 and F1295" and HA coating "as specified in ASTM F1185," implying compliance with these mechanical and material standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set."

Summary of the Device and Study (as per the provided text):

The SI-LOK™ Sacroiliac Joint Fixation System is a mechanical device consisting of screws and washers designed for sacroiliac joint fusion. Its clearance (K112028) was based on demonstrating substantial equivalence to existing predicate devices (Synthes Cannulated Screw, DePuy Spine SIJF Cannulated Screw System, Zyga Technology Slmmetry Joint Fusion System).

The "study" that proves the device meets the acceptance criteria (substantial equivalence) involved mechanical testing, specifically:

• Static cantilever bending
• Dynamic cantilever bending
• Screw insertion
• Screw pull-out

These tests were performed to show that the SI-LOK™ system's performance is comparable to that of the already legally marketed predicate devices, in terms of indications, design, materials, and performance. The specific quantitative results of these tests and their comparison to the predicates are not detailed in this summary. The materials used (titanium alloy, HA coating) conform to established ASTM standards.

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