(171 days)
The Iconix® HA+™ 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 Repar
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 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® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.
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 a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M 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.
This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Material Performance | UHMWPE sutures meet USP requirements for non-absorbable suture (except for diameter) | UHMWPE sutures tested per USP performance requirements for tensile strength. (Implicitly, the device met these, as it concluded substantial equivalence.) |
| Biocompatibility | ISO 10993-1:2018 - Biological Evaluation of Medical Devices | Biocompatibility testing performed per ISO10993-1:2018. An animal study was also performed. (Implicitly, the device met these, demonstrating biological safety.) |
| Sterilization | Sterilization adoption validation (likely internal protocol based on recognized standards) | Sterilization adoption validation performed. Device is sterilized by ethylene oxide gas and provided sterile. (Implicitly, the device met these.) |
| Packaging | ISO 11607-1:2006 - Packaging for terminally sterilized medical devices | Stability testing on product packaging per ISO 11607-1:2006. (Implicitly, the device met these.) |
| Usability | EN 62366: 2015 - Medical devices - Application of usability engineering | Usability engineering validation with simulated use in cadaveric models performed per EN62366:2015. (Implicitly, the device met these.) |
| Endotoxin/Pyrogenicity | ANSI/AAMI ST72:2019, USP , USP , USP | Endotoxin/pyrogenicity testing performed per specified standards. (Implicitly, the device met these.) |
| Mechanical Fixation | Comparison to predicate device (K173074) for insertion, cyclic, and pullout testing | "Results of performance testing for the Iconix® HA+TM Anchor device concluded that the device performed comparably to the predicate device and to other currently marketed All-Suture anchor devices in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix® HA+TM Anchor met all requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.
- Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
- Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
- Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device and study type.
- For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
- For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.
4. Adjudication Method for the Test Set
This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.
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. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
- Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
- Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.
8. The Sample Size for the Training Set
This is not applicable. This is a physical device, not an AI/software model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no training set.
§ 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.