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The iFuse Implant System is intended for sacroiliac fusion for conditions including 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.

The iFuse Implant System consists of cannulated triangular, titanium (Ti 6A1 4V ELI, ASTM F136/F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the SI joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters, and are provided sterile (gamma sterilization). Fenestrations allow packing of autograft and/or allograft material.

The provided text is a 510(k) summary for the iFuse Implant System® - iFuse-3D implant. It describes a medical device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information related to a study proving a device meets acceptance criteria via a performance study involving AI or human readers, nor does it describe specific acceptance criteria and reported device performance in the context of an AI-assisted diagnostic or assistive device. It primarily discusses mechanical, biocompatibility, and sterilization testing for an implantable device to demonstrate substantial equivalence to existing devices.

Therefore, without the requested information in the provided input, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI or diagnostic device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "performance testing" but it refers to mechanical (static and fatigue bending, pull-out), MR safety, LAL (endotoxin), and biocompatibility testing for an implantable bone fastener. It does not provide specific performance metrics or acceptance criteria for a diagnostic/AI device.
2. Sample sized used for the test set and the data provenance: Not applicable or provided for an AI system. The "test set" here refers to physical implants undergoing mechanical and other lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is typically established through material science standards, engineering specifications, and biological safety assessments, not expert image interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This study focuses on an implantable device, not a diagnostic or AI-assisted interpretation 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: For this medical device (an implant), ground truth relates to material properties, structural integrity, biocompatibility, and sterility, verified through laboratory testing.
8. The sample size for the training set: Not applicable. This document is not about an AI model with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes regulatory approval for a physical medical implant (iFuse Implant System® - iFuse-3D implant) and uses laboratory and mechanical testing to demonstrate substantial equivalence. It does not contain any information about an AI-powered diagnostic device, its performance studies, or related acceptance criteria.

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