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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 non-traumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System and the Medtronic StealthStation 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.

The TORQ iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse TORQ Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with 10.0 mm and 11.5 mm fully threaded iFuse TORQ implants.

The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions:

• 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.
• To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

When connected to compatible pedicle screw systems with 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fusion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System and the Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite 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.

The Granite iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Use of the iGPS instruments is limited to use only with 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.

SI-BONE's iGPS Navigation Instruments are navigated and reusable instrumentation compatible with the Globus ExcelsiusGPS Robotic Navigation System. The iGPS Navigation Instruments are designed to allow surgeons to place iFuse TORQ and iFuse Bedrock Granite implants using the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System) along with Globus ExcelsiusGPS® Instrument Trackers.

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

The iFuse TORO TNT Implant System is indicated for:

• Sacroiliac joint fusion for Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacrollitis. - 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 TORO TNT Navigation instruments are intended to be used with the iFuse TORO TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT 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 reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.

iFuse TORQ TNT System consists of a fully threaded, 3D-printed porous implant with optional washers along with instruments used to place the implant under either fluoroscopic guidance or with certain navigation systems. The implant is made from titanium alloy (Ti-6Al-4V ELI) and manufactured using 3D printing. The implant has features specific to pelvic anatomy. The subject device is very similar to its primary predicate, iFuse TORQ implant system, except that it is longer in length (up to 170 mm) and smaller in diameter. The longer length enables placement in the transiliac transsacral trajectory.

This is not a medical device with an AI/ML component. The information provided in the document focuses on the mechanical, material, and performance characteristics of the iFuse TORQ TNT™ Implant System and its navigation instruments, primarily through bench testing and comparison to predicate devices, rather than an AI/ML driven diagnostic or assistive tool.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices, such as specific performance metrics like sensitivity/specificity, sample sizes for training/test sets, human expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or detailed in this document.

The document discusses "iFuse TORQ TNT Navigation instruments" which are intended to "assist the surgeon in precisely locating anatomical structures," and uses "image data based model of the anatomy," but this navigation system is intended to be used with the Medtronic StealthStation System, a known image-guided surgery platform, and the focus of the submission is on the implant system and its mechanical performance, not the algorithmic performance of an AI/ML component for diagnosis or prediction.

Here's a summary of the available information based on the prompt's structure, highlighting where information is absent due to the device type:

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

Since this is a mechanical implant and navigation instrument system, the "acceptance criteria" are generally related to mechanical properties and functional equivalence to predicate devices, as demonstrated through various ASTM standards. Specific quantitative acceptance criteria or reported device performance metrics (e.g., specific thresholds for fatigue cycles, tensile strength) are not detailed within this 510(k) summary document. The document states that "The test results demonstrate that the device is substantially equivalent to the predicate device," indicating that the performance met the requirements for substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated in this 510(k) summary. Performance data refers to "testing" and "evaluation" against ASTM standards, which typically involve a specified minimum number of samples per test type.
• Data Provenance: The document implies benchtop testing of the physical device or its components. There is no mention of patient data (retrospective or prospective), nor country of origin for such data.

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

• This is not applicable as the evaluation is based on benchtop mechanical and material testing against established ASTM standards and substantial equivalence to predicate devices, not on diagnostic or AI performance requiring expert-established ground truth from medical images or clinical data.
• The Predetermined Change Control Plan (PCCP) mentions "review with experienced surgeons" for new trajectories, but this is for clinical application review, not for establishing ground truth for a test set in an AI/ML context.

4. Adjudication method for the test set

• Not applicable. This pertains to consensus among experts, which is not relevant for the type of testing described (benchtop mechanical and material performance).

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 not an AI/ML diagnostic or assistive device that would participate in an MRMC study. The "navigation instruments" are for surgical guidance, not for interpretation of medical images by human readers.

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

• Not applicable. This is an implant system and navigation instruments, not a standalone algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is derived from established engineering standards (ASTM and ISO) for mechanical properties, material composition, and functional characteristics, validated through benchtop testing. The concept of "expert consensus, pathology, or outcomes data" as ground truth is not relevant in this context. Substantial equivalence to predicate implant systems serves as a primary benchmark.

8. The sample size for the training set

• Not applicable. There is no AI/ML component described that would require a training set.

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

• Not applicable. There is no AI/ML component described that would require a training set or its associated ground truth establishment.

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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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