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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 joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

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 and K131405.

This document, an FDA 510(k) summary for the iFuse Implant System®, details a premarket notification for a medical device. However, it explicitly states that "No performance testing was required to support the modified labeling that is the subject of this 510(k)." Therefore, the document does not contain information on acceptance criteria or a study proving the device meets said criteria as it pertains to this specific submission.

The 510(k) is for a modification to labeling of an already existing and previously cleared device (iFuse Implant System). The submission focuses on demonstrating substantial equivalence to its predicate device rather than presenting new performance data.

Consequently, I cannot provide the requested information from the provided text, as the study details and acceptance criteria are not present.

Ask a specific question about this device

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838, K122074 and K123850.

The provided text is a 510(k) summary for the iFuse Implant System®, and it primarily discusses substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and a detailed analysis of device performance. The only "performance data" mentioned is related to MR compatibility.

Therefore, an extensive table of acceptance criteria and reported device performance, information about sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, training set details, or specific types of ground truth cannot be extracted from this document as these types of studies were not included in the submission.

Here's a summary of the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed as "Magnetic resonance (MR) imaging testing."

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

• Sample Size (Test Set): Not specified. The document states "Magnetic resonance (MR) imaging testing was performed" but does not give details about the number of implants or test conditions.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Not applicable. The MR imaging testing does not involve establishing ground truth through expert review in the way a diagnostic imaging study would. The ground truth for MR compatibility testing lies in meeting specific standards through physical testing.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which is not the nature of MR compatibility testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not performed. The data presented relates to MR compatibility, not clinical effectiveness studies comparing human readers with or without AI assistance.

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

Not applicable. This device is an implant, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance refers to the physical properties of the implant under MR conditions.

7. The Type of Ground Truth Used:

The ground truth for the MR compatibility testing is based on the standards themselves (ASTM F2052-06, ASTM F2182-11A, ASTM F2119-07, and ASTM F2503-08). Meeting these objective, predefined standards through physical testing constitutes the "ground truth" for MR safety and compatibility.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, and therefore, there is no "training set."

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

Not applicable. As there is no training set.

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The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-70mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838 and K122074.

This 510(k) summary for the iFuse Implant System® does not contain information about specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for performance claims (e.g., diagnostic accuracy for AI devices).

Instead, this submission is a modification to an already cleared device, primarily for labeling and range of sizes offered. Therefore, the core of the submission relies on demonstrating substantial equivalence to existing predicate devices rather than proving new performance against specific metrics.

Here's a breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) does not present acceptance criteria or device performance data in the traditional sense of a study designed to measure specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission's primary "acceptance criteria" is demonstrating substantial equivalence to the predicate device.

The document explicitly states: "No performance testing was required to support the modified labeling or range of sizes offered that are the subject of this 510(k)." This indicates that the FDA did not require new studies to evaluate the mechanical or clinical performance of the device beyond what was already established for its predicates. The "performance" being evaluated for this specific submission is around the modifications related to labeling and size ranges, which are deemed not to raise new questions of safety or effectiveness.

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 or clinical studies were required or conducted for this specific 510(k) submission, there is no test set or associated data provenance to report.

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. No new performance testing or clinical studies were required, thus no ground truth establishment by experts for a test set was conducted.

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

Not applicable. No new performance testing or clinical studies were required, thus no adjudication method for a test set was conducted.

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 an orthopedic implant (a physical device), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness are not relevant to this device.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

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

Not applicable. No new performance testing or clinical studies were required for this specific 510(k) submission. For the predicate devices on which this submission relies, the "ground truth" would have been established through a combination of biomechanical testing, material characterization, and potentially clinical outcomes from prior studies, demonstrating the safety and effectiveness of the device for its intended use.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/software device that requires a training set.

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

Not applicable. This is a physical orthopedic implant, not an AI/software device that requires a training set.

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