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The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.

This FDA 510(k) summary for the DYNAMIS™ SI Screw System does not describe an AI/ML device or a study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, and MRMC studies is not applicable.

The document primarily focuses on establishing substantial equivalence for a physical medical device (a sacrioiliac joint screw system) through mechanical performance testing against established ASTM standards and comparison to predicate devices.

However, I can extract the following relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "demonstrate[s] that the DYNAMIS™ SI Screw System is substantially equivalent to the predicate devices" for all tests, implying its performance met or exceeded the performance of the predicate devices based on these mechanical tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

The following numbered points are not applicable or cannot be extracted from the provided text as the document pertains to a physical medical device clearance, not an AI/ML software device performance study:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is not a study assessing AI/ML model performance on a dataset of patient data. The "test set" refers to the physical screws undergoing mechanical testing. While not specified, these would be a sample of the manufactured screws.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert labels on medical images) is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing mechanical test results against established 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 document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical AI/ML ground truth. For this device, the "ground truth" for performance is defined by the objective mechanical testing standards (ASTM F3574, ASTM F543) and comparison to the predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device that requires a training set or associated ground truth.

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