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The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.

When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.

The Dunamis Screw and Suture Locking System is to be used for fixation of bone-to-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 devices are intended to be used in the adult or pediatric patient population, when the device does not bridge, disrupt, or interfere with the growth plate.

The Dunamis Screw and Suture Locking System consists of standalone bone screws, and various components which are compatible with previously cleared Dunamis Fixation Button System, Force DFX sutures and suture tapes, including: screws with suture locking features and suture wheel with various adapter options. The standalone screws are provided in various diameters, lengths, and configurations including headed and headless styles with various overall and threaded lengths. Screws with suture locking features are available in various diameters, lengths, and configurations. The suture wheel is available for standalone use with sutures or for use with compatible orthopedic plates with two adapter options (threaded or non-threaded post). The new components are manufactured from stainless steel and titanium alloy.

This document is an FDA 510(k) clearance letter for a medical device called the "Dunamis Screw and Suture Locking System." It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific novel clinical performance or effectiveness through a clinical trial with acceptance criteria for an AI or software-based medical device.

Therefore, the requested information about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software would not be applicable to this type of traditional medical device clearance.

The clearance letter primarily discusses:

• Intended Use and Indications: For bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
• Device Description: Consists of standalone bone screws and components compatible with previously cleared Dunamis systems, manufactured from stainless steel and titanium alloy.
• Predicate Devices: Several predicate devices are listed, including screws and suture systems.
• Performance Testing Summary: "Non-clinical performance data included ASTM F543 screw testing, static and dynamic construct testing, and engineering worst-case rationales." This indicates bench testing to demonstrate mechanical performance comparable to the predicates.
• Substantial Equivalence Conclusion: The device has the same intended use, similar technological characteristics, and similar materials to the predicate devices. Mechanical testing demonstrated substantially equivalent performance.

In summary, this 510(k) clearance is for a physical orthopedic implant system, not a software or AI-based medical device. The "acceptance criteria" here are met through demonstrating mechanical properties and performance that are substantially equivalent to already cleared devices, primarily via non-clinical bench testing.

Thus, a table of acceptance criteria for AI performance, details on test/training sets, expert adjudication, MRMC studies, or specific AI ground truth establishment methods are not present and not relevant to this 510(k) submission as described.

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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.

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