(108 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (see Explanation below) | Not applicable (see Explanation below) |
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.
§ 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.