(29 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 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.
§ 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.