(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.
§ 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.