(104 days)
The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:
Hip Indications: Capsule Repair, Acetabular Labrum Reattachment
Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Rotator Cuff Repair, Biceps Tenodesis.
Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.
Elbow. Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.
The ICONN Square 2.5MM Suture Anchors (P/N 125000) are sterile (gamma irradiation), single use implantable devices made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The anchors are available in one size (Width x Length): 2.5mm x 7.95mm and can be used as a knotted or knotless anchor.
This document is related to a 510(k) premarket notification for a medical device, specifically the ICONN Square 2.5MM Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm or diagnostic device. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study proving its performance (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
The "acceptance criteria" for this device are based on its mechanical performance relative to predicate devices, ensuring it is at least as safe and effective.
Here's the information extracted from the provided text as it relates to the mechanical device, with an explanation of why certain AI-specific questions are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this mechanical device, "acceptance criteria" are embodied by demonstrating performance that is "similarly or better than the predicates or within acceptable ranges for the intended use."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Anchor displacement after cyclic loading "acceptable ranges" | Performed similarly or better than the predicates. |
| Ultimate anchor pull-out within "acceptable ranges" | Performed similarly or better than the predicates. |
| Insertion of the device is safe. | Insertion testing demonstrated the device can be safely implanted. |
| Biocompatibility: | |
| Biocompatibility equivalent to predicate devices. | Demonstrated substantial equivalence in biocompatibility to a predicate. |
| Sterility: | |
| Sterile (gamma irradiation). | Device is sterile via gamma irradiation. |
| Material: | |
| Material (PEEK) is suitable for intended use. | Made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of units tested for "anchor displacement after cyclic loading," "ultimate anchor pull-out," or "insertion testing." It refers to "side by side mechanical testing."
- Data Provenance: The testing was conducted in a laboratory setting as part of the premarket notification process for the manufacturer (ICONN Orthopedics, LLC). It is not clinical data from patients or a specific country of origin in the way an AI study would entail. It's not retrospective or prospective clinical data but rather engineering test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a mechanical device, not an AI algorithm requiring expert interpretation to establish a "ground truth" for diagnostic purposes. The "ground truth" here is objective mechanical measurements (e.g., force, displacement).
4. Adjudication Method for the Test Set
- Not Applicable. This concept applies to human interpretation of data where disagreements need resolution. Mechanical testing results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Not Applicable. An MRMC study is for evaluating the impact of a new diagnostic technology (often AI) on human reader performance. This device is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- In a sense, yes, for mechanical performance. The "standalone" performance here refers to the device's intrinsic mechanical properties (pull-out strength, displacement) in a test environment, independent of a surgical outcome. However, this is not an "algorithm" and does not relate to human-computer interaction.
7. The Type of Ground Truth Used
- Mechanical Measurement and Engineering Standards: The ground truth for this device's performance is derived from established mechanical testing standards and comparison to the performance characteristics of predicate devices. The FDA's "Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996)" was used for guidance.
- Biocompatibility: Demonstrated through equivalence to a predicate device (ICONN Answer Suture Anchor, K132724) which presumably had its biocompatibility established.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set was used.
§ 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.