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510(k) Data Aggregation
(87 days)
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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(165 days)
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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(126 days)
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.
| Criterion Type | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (Pain) | Implied: Demonstrate statistically significant improvement in SI joint pain. | INSITE Study: At both 6 and 12 months, showed improvement in SI joint pain in the iFuse implant group compared to the control group. |
| SIFI Study: Showed improvements in SI joint pain compared to baseline findings. | ||
| (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain... at 12 months post-implantation.") | ||
| Clinical Efficacy (Function) | Implied: Demonstrate statistically significant improvement in patient function/disability due to lower back/SI joint pain. | INSITE Study: At both 6 and 12 months, showed improvement in disability due to lower back pain in the iFuse implant group. |
| SIFI Study: Showed improvements in disability due to SI joint pain compared to baseline findings. | ||
| (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved... patient function... at 12 months post-implantation.") | ||
| Clinical Efficacy (QoL) | Implied: Demonstrate statistically significant improvement in quality of life. | INSITE Study: At both 6 and 12 months, showed improvement in quality of life (by two measures) in the iFuse implant group. |
| SIFI Study: Showed improvements in quality of life (by two measures) compared to baseline findings. | ||
| (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved... quality of life at 12 months post-implantation.") | ||
| Safety | Not explicitly stated as a separate criterion, but inherent in clinical trials for medical devices. The 510(k) process focuses on substantial equivalence to a predicate device, which implies an acceptable safety profile similar to the predicate. No specific safety data or adverse event rates are provided in this summary, but they would have been part of the full 510(k) submission. No new safety concerns were identified that would affect substantial equivalence. | The submission claims "no changes to the technological characteristics of the device" which likely implies the safety profile remains consistent with previous versions. The 510(k) determination itself implies that the FDA found the device to be substantially equivalent to predicates in terms of safety and effectiveness. |
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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(112 days)
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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