(28 days)
The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
The SImmetryTM Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws. The revised surgical technique manual for the new modified version of the SImmetry™ Sacroiliac Joint Fusion System contain instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.
The provided document is a 510(k) summary for a medical device modification, specifically for the "SImmetry™ Sacroiliac Joint Fusion System Modification." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about an AI/ML device or its performance criteria, study design, or results in the context of diagnostic accuracy.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in documents detailing the clinical validation of a diagnostic or AI-powered medical device, which is not the nature of this submission.
Summary of what the document does indicate:
- Device: SImmetry™ Sacroiliac Joint Fusion System
- Modification: The revised surgical technique manual for the new modified version contains instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.
- Purpose of Submission: To demonstrate substantial equivalence of the modified device to the predicate device (K102907).
- Conclusion: Equivalence is based on the same indications for use, design features, operational principles, material composition, and mechanical performance when compared to the predicate device.
- Impact of Modification: The document states that the modification does not affect the intended use, alter the fundamental scientific technology or performance of the device, or raise any new questions of safety or effectiveness. It also states that adding autologous graft material does not require testing to ensure substantial equivalence.
§ 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.