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The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

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

· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse TORQ Implant System consists of the iFuse TORQ Implants and associated Instruments. Implants are threaded, fenestrated, cannulated, 3D-printed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or a lag design that is provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

This 510(k) covers extension of the porous lattice surface over the entire shank of the Ø10.0 mm screws, an optimized laser path during additive manufacturing process, and use of two implants in the SAI (posteromedial) trajectory for sacroiliac joint fusion.

This looks like a 510(k) clearance letter for a medical device (iFuse TORQ® Implant System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable in this context.

The document discusses acceptance criteria and studies for the mechanical and material properties of the iFuse TORQ® Implant System, which is a physical implant for sacroiliac joint fusion and fracture fixation.

Here's the information relevant to the provided document, based on the non-AI device context:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. Instead, it lists the types of performance tests conducted and then concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device." This implies that the performance in these tests met the established criteria for substantial equivalence to the previously cleared predicate device.

2. Sample sizes used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes (number of implants tested) used for each of the listed bench tests.
• Data Provenance: The tests are "bench testing," meaning they are conducted in a laboratory setting, not with human or animal data. The provenance is internal laboratory testing by the manufacturer (SI-BONE Inc.) or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the studies are mechanical bench tests, not clinical studies reviewed by medical experts. The "ground truth" is defined by the physical properties and engineering standards (ASTM).

4. Adjudication method for the test set:

• This question is not applicable as the studies are mechanical bench tests, not clinical studies requiring adjudication. The results are quantitative measurements against established engineering 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:

• This question is not applicable. This device is a physical implant, not an AI/ML diagnostic or assistive tool.

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

• This question is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the performance data, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for material and mechanical testing of medical implants. The goal is to demonstrate that the modified device performs similarly to or better than the predicate device under these standardized conditions.

8. The sample size for the training set:

• This question is not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

• This question is not applicable. As above, there's no training set for a physical implant.

Summary of what the K241574 document does provide regarding acceptance and proof:

The document describes modifications to an existing device (iFuse TORQ® Implant System). The acceptance criteria for these modifications, and the proof that they are met, revolve around demonstrating that the modified device is substantially equivalent to its predicate device(s) in terms of safety and effectiveness.

This is primarily shown through:

• Bench Testing: Mechanical and material tests (Porosity, Static Shear, Static Fatigue, Static Tensile, Abrasion, Dynamic Cantilever, Static Torsion) were performed according to recognized ASTM standards.
• Conclusion of Equivalence: The submission concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device" and that "The differences in the technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness."

The FDA's clearance letter confirms this conclusion, stating that the device is "substantially equivalent... to legally marketed predicate devices."

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The iFuse TORQ® Implant System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.

• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and / or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse TORQ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

This 510(k) premarket notification is for the iFuse TORQ® Implant System, which is a medical device for sacroiliac joint fusion and fracture fixation of the pelvis. The submission is to request clearance for an additional trajectory for placement of the device. Since this is an update seeking clearance for an additional trajectory for an already cleared device, the submission focuses on demonstrating substantial equivalence to the existing cleared device and predicates rather than presenting novel performance studies typical for a new device's initial clearance. Typically, updates like this rely on existing performance data of the cleared device and rationale for why the new trajectory does not introduce new safety or effectiveness concerns.

Therefore, the provided document does not contain independent studies with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as one would expect for a novel AI/software device. Instead, it relies on the previous clearance of the iFuse TORQ Implant System (K222605) and demonstrates that the current changes do not raise new questions of safety and effectiveness.

Here's an analysis based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent." However, it does not provide a table of acceptance criteria or specific numerical performance metrics for the device itself or for any new trajectory. This suggests that the performance evaluation for this submission relies on demonstrating similarity to already cleared devices, rather than establishing new performance benchmarks for this specific modification.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a new test set or study conducted to evaluate the device with the new trajectory. The assessment is likely based on engineering analysis and comparison to existing data for the predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not mentioned in the provided text. This type of study is more common for diagnostic imaging AI algorithms and less so for implantable hardware modifications unless there's a significant impact on interpretation or surgical planning.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device (implant system), not a standalone algorithm. The iFuse TORQ Navigation instruments are intended for human-in-the-loop assistance.

7. The Type of Ground Truth Used:

Not applicable. No new ground truth data is mentioned for this specific submission. The existing clearance for the iFuse TORQ Implant System (K222605) would have relied on appropriate ground truth for its initial evaluation, likely including clinical outcomes, radiographic assessment, and potentially cadaveric or biomechanical testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML algorithm that requires a training set in that context. The "training" for such medical devices typically refers to design iterations, engineering tests, and potentially cadaveric studies prior to marketing authorization.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

In summary, for this particular 510(k) submission (K231689) requesting clearance for an additional trajectory for the iFuse TORQ Implant System:

The primary method of demonstrating acceptance criteria is by showing substantial equivalence to already legally marketed predicate devices. The document explicitly states:

• "The subject device has identical technological characteristics compared to the primary predicate device and similar technological characteristics compared to the additional predicates. Risk analyses confirm that the differences do not raise different questions of safety and effectiveness."
• "An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent."
• "The subject device has been shown to be substantially equivalent to the primary and additional predicate devices. The subject device has the same intended use and indications for use as the primary predicate and an indication for use that is similar to the additional predicate devices. The differences in the indications for use between the subject device and the additional predicate do not affect the safety and effectiveness of the device and do not alter the intended therapeutic, diagnostic, prosthetic, or surgical use of the device. The subject device is the primary predicate and has similar technological characteristics to the additional predicates. The differences in the technological characteristics between the subject device and the additional predicates do not raise different questions of safety and effectiveness."

This means that the "acceptance criteria" are implicitly met by demonstrating that the modified device (with the additional trajectory) is as safe and effective as the predicate devices, and that the changes do not introduce new risks or alter the fundamental function of the device in a way that would require new performance studies. The specific performance data and criteria would have been part of the original K222605 submission for the iFuse TORQ Implant System.

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The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

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

· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelyic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated Instruments. 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 or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-theshelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

The provided text is a 510(k) summary for the iFuse TORQ® Implant System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the way a diagnostic AI device or certain novel therapeutic devices might.

Therefore, the document does not contain any information about acceptance criteria, performance studies (like MRMC or standalone AI performance), test set characteristics, expert qualifications, adjudication methods, or training set details.

The "PERFORMANCE DATA" section (VII) simply states: "An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent." This typically refers to mechanical testing, biocompatibility, and other engineering performance tests relevant to the physical implant, rather than clinical performance metrics in the context of diagnostic accuracy.

In summary, the information requested in your prompt is not available in the provided FDA 510(k) submission document.

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The iFuse-TORQ Implant System is indicated for:
· Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis
· Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments. iFuse-TORQ implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ implants, that are available in various lengths and diameters, allow for packing of autograft and allograft materials.

The provided text describes the 510(k) premarket notification for the iFuse-TORQ® Implant System, primarily focusing on its substantial equivalence to predicate devices and the expansion of its indications for use.

Crucially, the document does not contain information about acceptance criteria for an AI/ML-based device, nor does it describe a study proving such a device meets acceptance criteria. The iFuse-TORQ® Implant System is a medical implant (a smooth or threaded metallic bone fixation fastener), and the performance data presented relates to mechanical testing (axial pullout, torsional strength, insertion, and removal torque) as per ASTM F543, which are standard for orthopedic implants, not for AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document describes a traditional medical device clearance, not an AI/ML device clearance.

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