(56 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.
The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse Implant System® consists of cannulated triangular, titanium 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).
The provided text is a 510(k) summary for the iFuse Implant System, which is a medical device. This document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.
Instead, the document focuses on:
- The iFuse Implant System as a medical device for sacroiliac fusion.
- Its indications for use.
- Comparing it to a predicate device (K182983).
- Stating that there are no changes to the technological characteristics of the device compared to the predicate, only an addition to the indications for use.
- Concluding that no performance testing was required for this specific 510(k) submission because the technological characteristics and intended use (despite the added indication wording) are unchanged from the predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML powered device from this document. The document explicitly states: "No performance testing was required to support the modified labeling that is the subject of this 510(k)."
§ 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.