Search Results

The Iconix Knotless Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The Iconix Knotless Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The size of the anchor of the subject device is 1.4mm. Iconix Knotless Anchor will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text pertains to an FDA 510(k) premarket notification for a medical device called the "Iconix Knotless Anchor." It outlines the device's description, intended use, and the basis for its substantial equivalence to a previously cleared predicate device.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a physical medical device (knotless anchor for soft-tissue to bone fixation), not an AI/ML algorithm.

Therefore, I cannot provide the requested information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the physical medical device described in the document.

The document discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) and other validations (shelf-life, sterilization, biocompatibility, packaging stability, usability engineering) to demonstrate that the device performs comparably to its predicate and meets requirements for its intended use. This is typical for physical medical devices but does not align with the AI/ML-focused questions in your prompt.

Ask a specific question about this device