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iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures 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-Navigation instruments are intended to be used with the Medtronic StealthStation System.

iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System®. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.

This document is a 510(k) summary for the iFuse Implant System - iFuse-Navigation Instrument Set. It describes a medical device, specifically a surgical instrument used with a navigation system for sacroiliac joint surgery, and asserts its substantial equivalence to a predicate device.

The provided text does not contain the detailed information required to answer your specific questions regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K172268) based on having the same intended use/indications for use, similar technological characteristics, and no changes in operating principle, component materials, manufacturing processes, or sterilization method.

The Section "VIII. SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES" states: "Performance testing conducted on the proposed device demonstrates that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The following testing were successfully performed for the 4.0 mm Navigation Broach: registration with Medtronic StealthStation and dimensional analysis."

This is a very high-level summary and does not provide the specific acceptance criteria or the reported performance data in a quantitative manner that would allow for the creation of the requested table. It also does not describe the study methodology in enough detail to answer questions about sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study that proves the device meets them based solely on the provided text. The document indicates that testing was performed, but it does not present the results or the details of those tests.

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The iFuse Implant System is intended for sacroiliac fusion 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 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.

The iFuse Implant System consists of cannulated triangular, titanium implants Ti-6A1-4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti-6A1-4V ELI, ASTM F3001 with a porous surface and an instrument system. The principle of operation is based on the triangular implant shape and porous surface which are designed to prevent and minimize motion / micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).

This document is a 510(k) Premarket Notification from SI-BONE, Inc. to the FDA regarding their iFuse Implant System®. It is a request for clearance to market an updated version of an existing device, and as such, it does not contain information about a new study with acceptance criteria and device performance as would be found for a novel device or a significantly modified one requiring new clinical data.

Specifically, the document states:

• "There are no changes to the technological characteristics of the device that are the subject of this 510(k)."
• "There were no changes in the design, technological features, intended use and overall risks associated with the iFuse Implant System. Therefore, no new design verification or validation testing was required; the design verification and validation testing previously conducted and submitted in previously cleared SI-BONE 510(k)s is applicable."

Therefore, I cannot provide the requested information from this document. The document explicitly states that no new design verification or validation testing was required for this 510(k) submission. This means there is no new study described within this filing that establishes acceptance criteria and then proves the device meets those criteria.

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

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

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

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

Instead, the document focuses on:

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

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

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The iFuse Implant System® consists of cannulated triangular, titanium (iFuse implants: Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTM F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new performance testing and thus no new ground truth establishment were conducted for this 510(k) submission.

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

The iFuse-Navigation instrument set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.

The provided text describes a 510(k) premarket notification for the iFuse Implant System - iFuse Navigation. Let's extract the requested information regarding acceptance criteria and the study proving the device meets them.

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

The document does not explicitly list quantitative acceptance criteria in a dedicated table format with reported device performance values. It describes the types of tests performed and implies that the device passed these tests to achieve substantial equivalence.

Based on the "Performance Data" section (Page 4), the following can be inferred:

Note: The document only states that testing was "completed to ensure the functionality and compatibility" and that "verification and validation results support substantial equivalence." No specific numerical thresholds or measured performance values are provided.

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

The document does not specify the sample size (e.g., number of tests, number of devices tested, number of simulated procedures) used for any of the performance tests.
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data).

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

The document does not refer to the use of experts to establish ground truth for the performance tests. The tests described (Registration, Accuracy, Rigidity, Compatibility) appear to be engineering verification and validation tests rather than clinical studies requiring expert interpretation of results against a medical ground truth.

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

No adjudication method is mentioned, as the tests do not appear to involve human interpretation necessitating such a method.

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 MRMC comparative effectiveness study was done or mentioned. This device is a surgical navigation instrument, not an AI diagnostic tool that assists human readers.

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

This is not applicable as the device is an instrument used with a navigation system and by a surgeon, not a standalone algorithm. The performance tests appear to be evaluations of the instrument's interaction with the navigation system and its physical properties.

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

The concept of "ground truth" as typically understood in medical device validation (e.g., against pathology for a diagnostic device) does not seem applicable here in the traditional sense. The "ground truth" for the performance tests would be the established engineering specifications, system requirements, and the expected functional behavior of the instruments in conjunction with the StealthStation® system and iFuse Implant System. The tests aim to verify that the device meets these pre-defined specifications.

8. The sample size for the training set

The document does not mention a training set. This is consistent with the nature of the device as a physical surgical instrument and not an AI/machine learning system that requires a training phase.

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

Not applicable, as no training set is discussed or implied.

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

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

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

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

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

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

1. A table of acceptance criteria and the reported device performance: The document mentions "performance testing" but it refers to mechanical (static and fatigue bending, pull-out), MR safety, LAL (endotoxin), and biocompatibility testing for an implantable bone fastener. It does not provide specific performance metrics or acceptance criteria for a diagnostic/AI device.
2. Sample sized used for the test set and the data provenance: Not applicable or provided for an AI system. The "test set" here refers to physical implants undergoing mechanical and other lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is typically established through material science standards, engineering specifications, and biological safety assessments, not expert image interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This study focuses on an implantable device, not a diagnostic or AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this medical device (an implant), ground truth relates to material properties, structural integrity, biocompatibility, and sterility, verified through laboratory testing.
8. The sample size for the training set: Not applicable. This document is not about an AI model with a training set.
9. How the ground truth for the training set was established: Not applicable.

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

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The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718, and K152681.

This document is a 510(k) summary for the iFuse Implant System®, a medical device intended for sacroiliac fusion. It is a submission to the FDA for market clearance, rather than a study designed to establish acceptance criteria and prove a device meets them in the context of an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies for AI performance is not present in the provided text.

The document primarily focuses on establishing "substantial equivalence" of the iFuse Implant System® to previously cleared predicate devices, an FDA regulatory pathway for non-AI/ML devices.

However, I can extract information related to the clinical evidence supporting the indications for use for this non-AI/ML device.

Clinical Evidence Related to Indications for Use (Not Acceptance Criteria for AI/ML):

The document states:
"Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life."

Study Information Pertaining to Clinical Efficacy (Not AI Performance):

• Study Name: SIFI (Sacroiliac Joint Fusion with iFuse Implant System)
• Study Type: Prospective, multicenter, single-arm clinical trial.
• Sample Size (Patients): 172 patients enrolled, with 149 patients followed for 24 months.
• Data Provenance: Not explicitly stated, but "multicenter" implies data from multiple sites, likely within one country or multiple, but the specific countries are not mentioned. It is a "prospective" study.
• Outcomes Measured: Clinically important and statistically significant improvements in:
  • SI joint pain
  • Disability due to SI joint pain
  • Quality of life (by two measures)
  • Patient satisfaction rates were high.
• Ground Truth: For this type of clinical trial, the "ground truth" would be the patient-reported outcomes (pain scores, disability indices, quality of life questionnaires) and clinician assessments, rather than a consensus of experts on a diagnostic image.
• Training Set/Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device study.
• Experts / Adjudication / MRMC Study / Standalone Performance: These are not relevant for this type of non-AI/ML device submission.

In summary, the provided text does not contain the specific details requested for an AI/ML device's acceptance criteria and the study proving it meets them. The document is for a traditional medical device (implant system) seeking 510(k) clearance based on substantial equivalence and clinical effectiveness data.

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The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with diameters of 4mm-7.0mm, 7.5mm, and 10.75mm. The iFuse Implants are implanted using instrumentation described in this submission as well as in K110838, K122074 K123850 K131405, K141049, K150714, K150875 and K151718.

The provided text is related to a 510(k) premarket notification for the iFuse Implant System, a medical device. This type of document is an FDA submission for a device that is substantially equivalent to a predicate device already on the market.

It is crucial to understand that this document explicitly states "No performance testing was required to support this premarket notification."

Therefore, based solely on the provided text, I cannot answer questions 1-9 regarding acceptance criteria and a study proving the device meets those criteria, as such information is not present. The document focuses on the regulatory aspects of substantial equivalence, not a detailed performance study proving compliance with specific acceptance criteria that would typically be found in a clinical trial report or a more extensive validation study.

The closest relevant information is the "Indications for Use," which mentions:
"Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation."

However, this is a summary statement about prior clinical studies (presumably for previous iterations or approvals of the iFuse system, given the numerous predicate devices listed) and does not constitute a "study that proves the device meets the acceptance criteria" within this specific 510(k) submission. It does not provide the detailed methodology, results, or acceptance criteria requested in your prompt.

Therefore, for questions 1-9, the answer is that the information is not available in the provided document, as no performance testing was required or reported for this specific 510(k) submission.

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714 and K150875.

Here's an analysis of the provided text regarding the iFuse Implant System and its acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state specific numerical acceptance criteria for the device's performance that would typically be seen in an AI/software device submission (e.g., Sensitivity > X%, Specificity > Y%). Instead, the submission focuses on clinical endpoints related to patient outcomes, consistent with a medical implant.

The reported device performance is described qualitatively and through the mention of improvement in specific clinical measures.

2. Sample Sizes Used for the Test Set and Data Provenance

• INSITE Study (Prospective Randomized Controlled Trial):

  • Total Patients: 148
  • iFuse Implant System Group: n=102
  • Non-Surgical Management (Control Group): n=46
  • Provenance: Prospective study. Country of origin not specified, but typically multi-center studies for FDA submissions include sites in the US and potentially other regions.

• SIFI Study (Prospective Multicenter Single-Arm Clinical Trial):

  • Total Patients: 172
  • Provenance: Prospective, multicenter study. Country of origin not specified.

• Retrospective Studies: Mentioned as contributing data, but no specific sample sizes or details are provided in this summary.

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

This information is not applicable in the context of this device submission. The iFuse Implant System is a physical medical device (implantable fusion rod), not an AI/imaging diagnostic device that relies on human experts to establish "ground truth" for image interpretation or algorithmic output in a test set. The "ground truth" for this device's effectiveness is established through clinical outcomes (pain, function, quality of life) measured directly from patients in clinical trials.

4. Adjudication Method for the Test Set

This information is also not directly applicable as it relates to expert review of data, typically for image interpretation or diagnostic accuracy. For the clinical trials (INSITE, SIFI), the "adjudication" would involve:

• Study Design: Blinding (in INSITE, participants were assigned to groups, but assessments like pain scales are patient-reported).
• Statistical Analysis: Used to compare outcomes between groups or against baseline.
• Independent Review Boards/Ethics Committees: Oversee the conduct of the studies.
• Clinical Endpoints: Defined measurements (e.g., VAS pain scores, Oswestry Disability Index, SF-36) are collected systematically from patients.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic imaging devices where multiple readers evaluate cases with and without the assistance of an AI system. The iFuse Implant System is a therapeutic device, not a diagnostic one.

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

No, this question is not applicable. The iFuse Implant System is a physical medical implant, not an algorithm or AI system. Its performance is evaluated through its direct therapeutic effect on patients.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness of the iFuse Implant System is based on patient-reported outcomes and objective clinical measures from the prospective clinical studies (INSITE and SIFI). These include:

• Pain levels: Likely measured using validated scales (e.g., Visual Analog Scale - VAS).
• Patient Function/Disability: Likely measured using validated scales (e.g., Oswestry Disability Index, Roland-Morris Disability Questionnaire).
• Quality of Life: Measured using validated instruments (e.g., SF-36).

For a device like this, these clinical outcomes are the primary indicators of "ground truth" regarding its efficacy.

8. The Sample Size for the Training Set

No information regarding a "training set" is applicable or provided in this 510(k) summary. "Training set" is a term used in the development of AI/machine learning algorithms. The iFuse Implant System is a physical device, and its development and validation do not involve machine learning training sets in the traditional sense.

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

This question is not applicable for the same reasons as #8. There is no training set as it's a physical medical device, not an AI/ML algorithm.

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049 and K150714.

This document is a 510(k) summary for the SI-BONE iFuse Implant System. It primarily addresses a clarification of existing labeling and explicitly states that no performance testing was required to support this clarification. Therefore, many of the requested details regarding acceptance criteria and study design are not present in this document.

Here's a breakdown based on the information available:

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

Not available. The document states: "No performance testing was required to support the clarification of existing labeling that is the subject of this 510(k)." This 510(k) is for a "clarification of existing labeling," not for demonstrating initial device performance or a new device.

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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. The iFuse Implant System is a medical implant, not an AI-assisted diagnostic device.

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

Not applicable. The iFuse Implant System is a medical implant, not an algorithm or AI system.

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

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

8. The sample size for the training set

Not applicable, as no performance testing was conducted for this 510(k), and the device is an implant, not an AI model requiring a training set.

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

Not applicable, as no performance testing was conducted for this 510(k), and the device is an implant, not an AI model requiring a training set.

Summary based on the provided document:

This 510(k) (K150875) for the SI-BONE iFuse Implant System is a "clarification of existing labeling." It explicitly states that no performance testing was required to support this particular submission. Therefore, it does not contain the information requested regarding acceptance criteria or performance study results. The device itself is an orthopedic implant, not an AI/software device, which explains why questions related to AI models and diagnostic performance are not relevant here.

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