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510(k) Data Aggregation
(268 days)
The ICONN Campbell Interference Screw System is intended for fixation of tissue, including ligament or tendon to bone for the following indications:
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Lateral Epicondylitis repair.
The ICONN Campbell Interference Screws (various part numbers) are sterile (gamma irradiation), single use implantable devices available in two materials: Solvay's Zeniva®ZA-600L polyetheretherketone (PEEK) or Ti 6Al-4 ELI (Grade 23) and is intended for fixation of tissue, including ligament or tendon to bone. The screws are available in multiple sizes ranging from diameters of Ø6mm - Ø12mm in 1mm increments. The Ø6mm screw is available only in 20mm long, the Ø7mm - Ø10mm screws are available in 20mm and 25mm lengths, and the Ø11mm and Ø12mm screws are available in 25mm lengths only.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the ICONN Campbell Interference Screw:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Axial Pullout Strength (after cyclic loading) | Similar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use. | Performed similarly or better than the predicate OR within acceptable ranges for the intended use. |
| Displacement during Cyclic Loading | Similar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use. | Performed similarly or better than the predicate OR within acceptable ranges for the intended use. |
| Torsional Properties (Insertion Testing) | Device can be safely implanted. | Testing results showed that the device can be safely implanted. |
| Driving Torque (Insertion Testing) | Device can be safely implanted. | Testing results showed that the device can be safely implanted. |
| Biocompatibility | ||
| Cytotoxicity | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Irritation | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Sensitization | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Endotoxin (LAL Test) | < 0.05 EU/device (in accordance with ANSI/AAMI ST72:2016). | < 0.05 EU/device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the mechanical testing (axial pullout, cyclic loading, torsional properties, driving torque). It mentions that "the version of the screw made out of PEEK material was tested, as that material constitutes a worst case between the two materials offered." For the LAL testing, it states "One (1) each of the test articles were placed in 10 mL of Water for Injection."
The data provenance is not specified in terms of country of origin. The study appears to be prospective in nature, as it involves testing a newly developed device against pre-established standards and a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical implant, and the "ground truth" for its performance is established through physical and chemical testing against engineering standards and comparison with a predicate device, not through expert human interpretation of data like in an AI/imaging study.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective physical and chemical test results, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human readers interpret medical images or data. The ICONN Campbell Interference Screw is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation described is entirely "standalone" in the sense that it pertains to the physical device itself, independent of human interaction beyond implantation. There is no AI algorithm involved.
7. The Type of Ground Truth Used
The ground truth used for this device is based on engineering standards (ASTM F543-2013, ISO 10993-1:2009/(R)2013, ANSI/AAMI ST72:2016) and comparative performance metrics with a legally marketed predicate device (Arthrex PEEK Interference Screw, K062466).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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