(106 days)
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distributing suture tension over areas of ligament or tendon repair.
Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The Dunamis Fixation System consists of titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports.
The provided text describes a FDA 510(k) premarket notification for the "Dunamis Fixation Button System." The document extensively details the device's administrative information, indications for use, device description, predicate devices, and the claim of substantial equivalence based on non-clinical testing.
However, the document does not contain information about a study involving human-in-the-loop performance, AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by multiple experts. It also does not mention any training or test sets for an AI/algorithm.
The "study" mentioned in the document refers to non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not clinical studies involving human readers or AI performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithm as it is not present in the provided text.
Specifically, the document states:
"Non-clinical testing performed included static testing, dynamic testing, sterilization, sterile barrier packaging performance and aging of sterile medical device. The non-clinical performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Fixation Button System (with Continuous Loop or Adjustable Loop) are substantially equivalent to the predicate device, Arthrex TightRope (K112990)."
This indicates that the "study" was focused on the physical and mechanical properties of the device, not on diagnostic performance or AI-assisted interpretation.
§ 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.