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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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The SI-BONE Trackers and Universal Pin Guide are intended to enable navigation of SI-BONE instrumentation during spinal surgical procedures that utilize Medtronic StealthStation™ Systems and Stealth™ Technology. The SI-BONE Trackers and Universal Pin Guide are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, finages, or digitized landmarks for the anatomy.

SI-BONE's Navigation Tracking Instruments ("Trackers") consist of fixed and rotating elements and a pin guide. The Trackers are reusable and made from aluminum and stainless steel. The Trackers have fixed elements (posts) that support connection with reflective spheres. The Trackers can be securely attached to instruments used to place SI-BONE's implants during surgical procedures. SI-BONE's Fixed Trackers replicate the function of the Medtronic TeraTrackers. SI-BONE's Rotating Trackers replicate the function of Medtronic NavLock Trackers. SI-BONE's Universal Pin Guide replicates the function of the Medtronic Universal Drill Guide. An additional instrument is included with Fixed Trackers to allow the attachment and removal of the Fixed Trackers from the navigated instrument mounts.

This document describes the SI-BONE Navigation Tracking Instruments, which include Trackers and a Universal Pin Guide. These instruments are designed to facilitate navigation of SI-BONE instrumentation during spinal surgical procedures using Medtronic StealthStation™ Systems and Stealth™ Technology.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a tabular format for each test. Instead, it states that "All product specifications were met" for positional testing and that biocompatibility and dimensional verification were assessed.

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

• The document does not specify the sample size used for the positional testing or dimensional verification. It simply states that testing "underwent and passed testing" and a "one-to-one dimensional comparison was conducted."
• There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature) as these are performance tests of the physical device, not a study involving patient data.

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

• This information is not applicable to the type of testing described. The tests performed (biocompatibility, positional accuracy, dimensional verification) are engineering and performance validation tests of the physical device, not studies requiring expert interpretation of medical images or clinical outcomes to establish a "ground truth." The ground truth for positional accuracy would typically be established by precise metrology instruments following a standardized protocol (like ASTM F2554-2018).

4. Adjudication Method for the Test Set:

• This information is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in studies where human reviewers or experts are assessing cases to establish a consensus ground truth, which is not the nature of the described performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not conducted or described. The document focuses on the technical performance of the navigation tracking instruments themselves, not their impact on human reader performance or diagnostic accuracy.
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. This device is an instrument for surgical navigation, not an AI diagnostic tool.

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

• The device described is a physical instrument (Navigation Tracking Instruments). It is not an algorithm or software that would have a "standalone" performance in the sense of a diagnostic AI without human interaction. Its performance is intrinsically linked to its interaction with the Medtronic StealthStation™ Systems (which include hardware, software, tracking algorithms). The "positional testing" could be considered an assessment of the system's performance with the new instruments, which includes the algorithm's ability to track them.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1) or by demonstrating equivalence to materials and processes of previously cleared, biocompatible devices.
• Positional Testing: Ground truth is established by the specified guidance in ASTM F2554-2018 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. This standard dictates methodologies for precisely measuring and verifying the accuracy of such systems, likely involving highly accurate reference measurements.
• Dimensional Verification: Ground truth is established by precise metrological measurements of the device's geometry and direct comparison to the dimensions of the predicate devices.

8. The Sample Size for the Training Set:

• This information is not applicable. The SI-BONE Navigation Tracking Instruments are physical devices, not an AI/machine learning model that undergoes "training." The testing performed validates the device's physical and functional specifications.

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

• This information is not applicable as there is no "training set" for physical instruments.

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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 screws 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 screws 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: 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 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. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse Bedrock Granite® Implant System consists of various lengths and diameters, and associated instruments sets. Instrument sets are provided for both open and minimally invasive approaches. The titanium (Ti-6A1-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the iliac trajectories. Additionally, iFuse Bedrock Granite can be placed into the S1 pedicle. The device is designed for connection to commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm titanium alloy or cobalt chrome alloy spinal fixation rods.

This FDA 510(k) summary document for the iFuse Bedrock Granite® Implant System does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the document primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical benchtop testing rather than clinical performance or AI/software-related performance metrics.

Here's a breakdown of what can be extracted and what is missing:

The device is a medical implant system and instruments, not an AI or software-only device. Therefore, questions related to AI performance, such as sample sizes for test/training sets, ground truth establishment for AI, expert numbers for ground truth, adjudication methods, and MRMC studies, are not applicable in this context.

Information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several performance tests according to ASTM standards. It states: "The test results demonstrate that the device is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., minimum load, maximum deformation) and the numerical results (reported device performance) for each test are not provided in this summary. It only lists the types of tests performed.

Information that is missing or not applicable based on the document:

• 2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are benchtop mechanical tests, not clinical studies with patient 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 for mechanical bench testing is typically defined by engineering specifications and material properties, not expert clinical consensus from images.
• 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: Not applicable. This is a mechanical implant, not an AI diagnostic or assistive device. The navigation instruments are mentioned, but no performance data is provided for them, let alone an MRMC study comparing human performance with and without AI assistance for these instruments.
• 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 (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device against which the subject device's performance is compared for substantial equivalence. No clinical ground truth types are mentioned.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) pertains to a physical medical device (implant system) and its mechanical performance, rather than an AI-driven software device. Therefore, many of the requested details related to AI performance metrics, clinical studies, and expert-established ground truths are not present or relevant in this document. The "study" proving acceptance criteria is a series of mechanical benchtop tests demonstrating substantial equivalence to a predicate device.

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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 Bedrock Granite® Implant System is intended for sacroiliac joint fusion for the following conditions:
· 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

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 Grante 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

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 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. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse Bedrock Granite® Implant System consists of implants of various lengths and diameters, and associated instruments sets (for both open and minimally invasive [MIS] approaches). The titanium (Ti-6Al-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to compatible pedicle screw fixation systems in both the SAI and the Iliac trajectories. It is designed for connection to compatible commercially available pedicle screw systems via Ø5.5 mm or Ø6.0 mm diameter circular titanium alloy or cobalt chrome alloy spinal fixation rods. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods.

The provided text describes a 510(k) premarket notification for the iFuse Bedrock Granite® Implant System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about a study based on AI/ML models or human-in-the-loop performance, nor does it refer to acceptance criteria related to such studies.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance related to an AI/ML study.
• Sample size used for the test set or its provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily discusses mechanical testing to demonstrate the device's compatibility and structural integrity with existing spinal fixation systems. The "Performance Data" section (Page 6) states:

• "SI-BONE performed the following mechanical testing of the connection of the Bedrock Granite tulip to commercially available representative rods."
• "Static Axial Grip per ASTM F1798 (axial gripping capacity)"
• "Static Axial Torsion Grip per ASTM F1798 (torsional gripping capacity)"
• "Dynamic Axial Compression per ASTM F1717 (dynamic compression bending)"
• "Testing was performed on a range of rod diameters and manufacturing methods to demonstrate compatibility with the iFuse Bedrock Granite® Implant System."
• "The test results demonstrate that the device is substantially equivalent to the legally marketed predicate device and does not raise different questions of safety and effectiveness compared to the predicate device."

This indicates that the "study" proving the device meets acceptance criteria is a series of mechanical tests according to specific ASTM standards, not a clinical or AI/ML performance study. The acceptance criteria would be the pass/fail thresholds defined by those ASTM standards for the mechanical properties tested (e.g., specific load capacities, bending resistance). The "reported device performance" would be the measured values from these mechanical tests.

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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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The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions: ·Sacrollac 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 period and have persisted postpartum for more than 6months. • To augment immobilization and stabilization of the sacroliac 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 When connected to the SeaSpine Mariner Pedicle Screw System, 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 withdegeneration 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 The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant 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. iFuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.

The iFuse Bedrock Granite™ Implant System consists of implants of various lengths and diameters, and associated instruments sets (Open and MIS). The titanium (Ti-6AI-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to the SeaSpine Mariner Pedicle Screw System in both the SAI and the Iliac trajectories. It is designed for connection to the SeaSpine Mariner Pedicle Screw System via Ø5.5mm or Ø6.0mm titanium alloy or cobalt chrome spinal fixation rods.

This document describes the regulatory clearance of the iFuse Bedrock Granite™ Implant System. It does not describe an AI/ML medical device, and therefore the provided information does not include the details required to answer your specific questions regarding acceptance criteria and performance studies for such devices.

The document is a 510(k) summary for a medical implant system and its associated navigation instruments. It focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use and Indications for Use: The conditions the device treats and its purpose.
• Technological Characteristics: The design, materials (titanium), and how it functions.
• Manufacturing Methods: How it's produced.
• Principles of Operation: How it achieves its intended effect.
• Performance Data: Primarily biocompatibility and mechanical testing (e.g., bending, torsion, pullout, fatigue) to ensure the device is safe and performs as expected under physical stresses.

Therefore, I cannot provide the detailed information requested in your prompt (e.g., acceptance criteria for an AI model's performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) because this 510(k) summary does not pertain to an AI/ML device.

The document states: "Any differences between the iFuse Bedrock Granite Implant System and the predicate devices do not raise any different questions of safety or effectiveness, as demonstrated by the results of the verification and validation testing." The "performance data" section lists the types of tests done (Biocompatibility Testing and Mechanical Testing), which are standard for implantable hardware. There is no mention of algorithms, AI/ML, or image analysis performance metrics.

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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 small and large bones of the pelvis

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments which are included in two Instrument Sets: iFuse-TORQ Instrument Set and iFuse-TORQ Revision Instrument Set. The iFuse-TORQ Implant System is designed to provide a non-impacted, threaded solution for sacroiliac joint fusion, as well as compression across the SI joint, and for fracture fixation of small and large bones of the pelvis.
The iFuse-TORQ Implants are sterile, single use 3D-printed implants that are provided in various lengths and diameters, and feature flutes and multiple fenestrations along the shaft length (Table 1). The iFuse-TORO Implants are provided in two primary configurations – fully threaded and lag implant designs with optional washers. The cannulated implants include a tapered distal tip and dualsingle-dual lead threads that are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ Implant designs allow for packing of autograft and allograft materials.
The iFuse-TORO Instruments are provided in two sets: iFuse-TORO Instrument Set (with Primary and Navigation Instruments) and the iFuse TORO Revision Instrument Set. The iFuse-TORO Instruments Sets consist of single use, disposable and reusable instruments. The instruments are provided non-sterile and are intended for cleaning and steam sterilization by the user prior to each use. The iFuse-TORQ Instruments consist of both Class II and Class I medical devices which facilitate the introduction, adjustment / positioning, final placement, and removal (if required) of the implants in the target anatomy.

The provided text describes the regulatory clearance of a medical device, the iFuse-TORQ™ Implant System. It details its purpose, technical specifications, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.

However, the document focuses on the mechanical and material-based acceptance criteria and testing for the implant system itself, rather than the performance of an AI/algorithm-based device.

Specifically, the "Study that proves the device meets the acceptance criteria" in this document refers to bench testing of physical properties, sterilization validation, biocompatibility, and packaging, as listed in Table 2. It does not describe a study involving an algorithm's performance, human readers, or image analysis.

Therefore, many of the requested criteria for an AI/algorithm-based device cannot be answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

Cannot be extracted from the provided document (related to AI/Algorithm performance):

• Table of acceptance criteria and reported device performance for an AI/Algorithm: The document lists standards for physical properties, sterilization, etc., not for AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample size used for the test set (for an AI/Algorithm): No test set of medical cases/images for AI evaluation is mentioned.
• Data provenance (e.g., country of origin, retrospective/prospective): Not applicable to the presented physical/material testing.
• Number of experts and their qualifications for ground truth: No expert review of cases/images is described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study involving human readers and AI assistance is mentioned.
• Stand-alone (algorithm only) performance: No algorithm is described.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable to the physical device testing.
• Sample size for the training set (for an AI/Algorithm): Not applicable, as there's no AI/algorithm.
• How ground truth for the training set was established: Not applicable.

What can be extracted, interpreting "device" as the iFuse-TORQ™ Implant System:

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

   The document lists various standards (acceptance criteria) that the device was tested against. The "reported device performance" is implicitly stated as meeting these standards, leading to the "substantially equivalent" determination. However, the specific quantitative results of each test (e.g., exact fatigue life, specific shear strength values) are not provided in this summary.

   Acceptance Criteria (Standards Met/Evaluated against)	Type of Test/Performance Demonstrated (Reported)
   SS EN ISO 11137-1, 2, 3	Sterilization Validation (Implants)
   ANSI / AAMI / ISO 11737-1, 2	Sterilization Validation (Implants)
   ANSI/AAMI/ISO 17665-1, AAMI TIR12, ANSI/AAMI ST79, ST77	Sterilization Validation (Instruments)
   EN ISO 19227, ISO 10993-5	Cleaning Validation (Implants)
   AAMI TIR30	Cleaning Validation (Instruments)
   AAMI TIR12, TIR17	Repeat Cleaning & Steam Sterilization (Instruments)
   EN ISO 11607-1, ASTM D4332-14, D4169-16, F2096-11, F88-15	Packaging Validation (Implants & Instruments)
   ASTM F1980-16	Shelf Life Rationale (Implants)
   ISO 10993-1	Biocompatibility Assessments (Implants & Instruments)
   ASTM F543-17, F2193-20	Bench Testing (Implants & Instruments), Torsion Testing (Implants)
   ASTM F3001-14	Elemental Analysis (Implants)
   ASTM F2193-20	Fatigue Testing (Implants)
   ASTM F1854-15	Stereological Evaluation of Porous Layer
   ASTM F1044-05	Static Shear Testing
   ASTM F1160-14	Shear Fatigue Testing
   ISO 13179-1, ASTM F1147-05	Static Tensile Testing
   ASTM F1978-18	Abrasion Properties
   ASTM F2052-15, F2119-13, F2182-19e2, F2213-06, F2503-13	MR Compatibility Assessment
   ASTM F2554-2018	Positional Error (Navigational Instruments)
   ANSI/AAMI HE75, EN 62366, IEC 62366-1	Simulated Use Testing (System Validation)

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

   • Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of implants tested for fatigue). It generally states "comprehensive Design Verification and Validation Testing."
   • Data Provenance: Not applicable in the context of human data. The testing was laboratory-based, performed by SI-BONE.

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

   • Not applicable to the type of testing performed. Ground truth for material and mechanical properties is established through standardized testing methods, not expert consensus on cases.

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. This document does not pertain to an AI-assisted diagnostic device, but rather a physical implant system.

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

   • No. This is not an algorithm.

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

   • For the physical device, the ground truth is established by the specifications defined in the relevant ASTM, ISO, and AAMI standards for materials, manufacturing, sterility, biocompatibility, and mechanical performance.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device.

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

   • Not applicable, as this is not an AI/ML device.

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