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The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the 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 TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.

I am sorry, but the provided text focuses on the regulatory clearance (510(k) submission) of the TransLoc 3D device. It outlines the device's indications for use, its description, and its substantial equivalence to a predicate device based on non-clinical testing and technological characteristics comparison.

The document does not contain any information regarding acceptance criteria, reported device performance metrics, particulars of a study (like sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or details about training sets.

Therefore, I cannot provide the requested table and study information based on the given text.

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TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

The TransLoc 3D System implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint.

The provided document is a 510(k) summary for the TransLoc 3D device, which is a sacroiliac joint fusion implant. The document does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop performance.

Instead, it details the non-clinical testing performed to demonstrate substantial equivalence of the TransLoc 3D device to predicate devices, primarily focusing on mechanical and material properties.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance as it relates to AI/diagnostic studies, human readers, or ground truth establishment in that context. The document only covers the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of "acceptance criteria" in the traditional sense of performance metrics for an AI-driven device (e.g., sensitivity, specificity). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices:

The document states that "No FDA performance standards have been established for TransLoc 3D." The acceptance criteria are implicitly that the device performs equivalently to the predicate devices in the listed mechanical and material tests.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical, mechanical, and material testing, not a diagnostic or AI performance study with a test set of human data.

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 diagnostic AI (e.g., expert labels on images) is not relevant to the non-clinical tests described.

4. Adjudication method (e.g., 2+1, 3+1, none) 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: No, an MRMC study was not done, as this document concerns a medical implant, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the established mechanical properties and material composition as defined by the ASTM standards and USP .

8. The sample size for the training set: Not applicable. There is no AI training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

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