(90 days)
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 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 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 inserter is comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The anchor size will be available in 1.4mm with working sutures in standard USP size 2. Iconix® Knotless Anchor will be sold sterile for single use with no components or accessories.
The provided document is a 510(k) summary for the Iconix® Knotless Anchor, a medical device used for soft-tissue to bone fixation. It describes the device, its intended use, and its equivalence to a predicate device (Stryker ICONIX Anchors).
However, this document does not contain any information about a study involving AI/algorithm performance or human-in-the-loop studies. It focuses solely on the mechanical and biological safety of the physical medical device (the knotless anchor itself) in comparison to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/algorithm performance. The document only discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) to demonstrate performance comparability of the physical anchor to a predicate device, and standard safety validations (sterilization, biocompatibility, stability, usability engineering).
In summary, there is no information in the provided text that relates to:
- Acceptance criteria for an AI/algorithm (e.g., sensitivity, specificity, AUC)
- Sample sizes for algorithm testing (test sets, training sets)
- Data provenance for AI/algorithm development or testing
- Number/qualifications of experts for AI ground truth
- Adjudication methods for AI ground truth
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth for AI (pathology, outcomes data, etc.)
- Training set size or ground truth establishment for an AI algorithm
The document focuses on the equivalency of a physical medical device (a bone anchor) and its mechanical properties.
§ 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.