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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 sacroilitis. 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 is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse Implant System® consists of cannulated triangular, titanium 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 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).

The provided text is a 510(k) summary for the iFuse Implant System, which is a medical device. This document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

Instead, the document focuses on:

• The iFuse Implant System as a medical device for sacroiliac fusion.
• Its indications for use.
• Comparing it to a predicate device (K182983).
• Stating that there are no changes to the technological characteristics of the device compared to the predicate, only an addition to the indications for use.
• Concluding that no performance testing was required for this specific 510(k) submission because the technological characteristics and intended use (despite the added indication wording) are unchanged from the predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML powered device from this document. The document explicitly states: "No performance testing was required to support the modified labeling that is the subject of this 510(k)."

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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 (iFuse implants: Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTM 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 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).

This document is a 510(k) summary for the iFuse Implant System®, which is seeking clearance for a modified labeling of an existing device. Therefore, it specifically states that no new performance testing was required to support this 510(k). This means there is no study described within this document that "proves the device meets the acceptance criteria" under this specific submission.

The document is a clearance for a medical device (iFuse Implant System) based on substantial equivalence to a predicate device (iFuse Implant System, K162733). The clearance is for an expanded indication for use.

Here's a breakdown of the requested information based on what is available (or explicitly stated as not applicable) in the provided text:

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

The document explicitly states: "No performance testing was required to support the modified labeling that is the subject of this 510(k)." and "The intended use, indications for use and the technological characteristics are unchanged compared to the predicate device and support that the proposal contained within this 510(k) is substantially equivalent to the predicate device."

This means that for this particular submission (K182983), no new acceptance criteria or new device performance data were generated or reported. The device is cleared based on the substantial equivalence to a previously cleared version of the same device, which would have had its own acceptance criteria and performance data. This document does not provide those original criteria or data.

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

Not applicable, as no new performance testing was conducted for this 510(k) submission.

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, as no new performance testing and thus no new ground truth establishment were conducted for this 510(k) submission.

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

Not applicable, as no new performance testing was conducted for this 510(k) submission.

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 is a physical implantable device, not an AI or imaging diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This is a physical implantable device, not an algorithm.

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

Not applicable, as no new performance testing was conducted for this 510(k) submission.

8. The sample size for the training set

Not applicable, as this is a physical implantable device and does not involve a "training set" in the context of machine learning or algorithms.

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

Not applicable, as this is a physical implantable device and does not involve a "training set" in the context of machine learning or algorithms.

In summary: The provided document is an FDA clearance letter and 510(k) summary for an expanded indication for use of an existing medical device. It explicitly states that no new performance testing was required for this submission because the device's technological characteristics are unchanged from its predicate, and thus, it did not need to generate new acceptance criteria or performance data for this clearance.

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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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