(29 days)
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. Iconix Knotless Anchors are available in common sizes and lengths and 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 classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.
This document is a 510(k) Pre-market Notification for a medical device called the "Iconix Knotless Anchor." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable based on the provided text.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it describes comparative performance testing against a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Iconix Knotless Anchor) |
|---|---|---|
| Biocompatibility | N/A (Tested per ISO 10993-1:2018) | Met requirements |
| Packaging Stability | N/A (Tested per ISO 11607-1:2006) | Met requirements |
| Usability Engineering | N/A (Tested per EN 62366:2015 via simulated use in cadaveric models) | Met requirements |
| Insertion Strength | Comparable to predicate device | Performed comparably |
| Cyclic Testing | Comparable to predicate device | Performed comparably |
| Pullout Testing | Comparable to predicate device | Performed comparably |
| Suture Tensile Strength | Meet USP performance requirements (except for diameter) | Met USP performance requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the mechanical tests (insertion, cyclic, pullout). It mentions "simulated use in a cadaveric models" for usability engineering, but the number of cadaveric models is not provided, nor is the country of origin. The data provenance details are largely absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes engineering and biocompatibility testing, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication method for the test set
This is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a surgical anchor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a surgical anchor.
7. The type of ground truth used
For mechanical testing (insertion, cyclic, pullout), the "ground truth" would be the measured mechanical properties of the device itself and the predicate. For biocompatibility, it's compliance with ISO standards. For packaging and sterilization, it's compliance with relevant ISO standards and validation protocols. For the usability engineering, it was simulated use in cadaveric models.
8. The sample size for the training set
This is not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.