(21 days)
The Iconix 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 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 or more working sutures.
Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The standard and the self-punching 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 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 appears to be an FDA 510(k) summary for a medical device called the "Iconix Anchor," which is a soft-tissue to bone fixation device. The prompt asks to describe the acceptance criteria and study that proves the device meets the criteria, particularly in the context of an AI/ML-enabled medical device.
However, the provided text does NOT describe an AI/ML-enabled medical device. It describes a physical medical device (an anchor for soft tissue fixation) and its non-clinical performance testing. Therefore, I cannot answer the questions directly as they pertain to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or training/test set ground truth establishment for AI.
The document discusses:
- Device Name: Iconix Anchor
- Intended Use/Indications for Use: Soft tissue to bone fixation in various anatomical locations (foot, ankle, knee, hip, hand, wrist, elbow, shoulder).
- Performance Data (Non-Clinical):
- Shelf-life testing
- Sterilization adoption validation
- Biocompatibility testing (per ISO10993-1:2018)
- Stability testing on packaging (per ISO 11607-1:2006)
- Usability engineering validation (with simulated use in cadaveric models per EN62366:2015)
- Non-clinical mechanical testing: insertion, cyclic, and pullout testing compared to a predicate device (K231078 – All-Suture Anchor).
- Conclusion: The device is substantially equivalent to the predicate device, with differences in suture size and anchor materials that were assessed through risk analysis and do not raise new questions of safety or effectiveness.
Therefore, based on the provided text, it's impossible to answer the prompt's specific questions about AI/ML device acceptance criteria and study details. The document does not contain any information about AI/ML performance, sample sizes for AI training/test sets, expert adjudication for AI ground truth, or MRMC studies.
If the prompt was mistakenly applied to this document, and the intent was to understand the general non-clinical acceptance criteria described in the document for this physical device, it would involve demonstrating:
- Biocompatibility (meets ISO10993-1)
- Sterility assurance
- Packaging integrity and shelf-life (meets ISO 11607-1)
- Usability (per EN62366)
- Mechanical performance (insertion, cyclic, pullout strength) is comparable to the predicate device. The "acceptance criteria" here is "performed comparably to the predicate device" for these mechanical tests.
Without an AI/ML component, the requested table and details are not applicable as phrased.
§ 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.