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The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone.

In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins.

The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "LINK™ External Fixator." This document details the device, its intended use, comparison to a predicate device, and the basis for its substantial equivalence determination.

However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document.

The text focuses on mechanical bench testing to demonstrate the device's physical performance characteristics, such as:

• Construct pull out
• 4-point bending for bone pin
• 4-point bending for fixator construct in a bone analog
• Static ultimate strength in tension bending
• Fatigue in tension bending
• LINK™ force applied to bone

It explicitly states: "Performance Data: Bench testing included construct pull out, 4-point bending for bone pin, 4-point bending for fixator construct in a bone analog, static ultimate strength in tension bending, fatigue in tension bending and the LINK™ force applied to bone."

This is a physical medical device, not an AI or software-based diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, clinical accuracy, MRMC studies, human reader improvement with AI assistance, independent algorithm performance) are not applicable here.

In summary, based only on the provided text, I cannot fill out the requested table or answer the questions related to clinical study performance, AI component validation, or expert-based ground truth because the document describes a traditional mechanical medical device cleared based on bench testing and comparison to a predicate device, not clinical validation of diagnostic performance.

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