(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
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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.
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SIFI Study (Prospective Multicenter Single-Arm Clinical Trial):
- Total Patients: 172
- Provenance: Prospective, multicenter study. Country of origin not specified.
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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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.