(100 days)
The Arthrex PCL TightRope is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
The proposed PCL TightRope consists of an adjustable non-absorbable suture loop, and 2 titanium buttons.
The PCL TightRope is deemed substantially equivalent to the previously cleared Arthrex ACL TightRope and the Arthrex BioComposite Interference Screw. The device's substantial equivalence is supported by mechanical and biomechanical testing demonstrating comparable ultimate load and cyclic displacement to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (PCL TightRope) |
|---|---|---|
| Ultimate Load | Substantially equivalent to Arthrex BioComposite Interference Screw | Demonstrated substantial equivalence to the predicate device. |
| Cyclic Displacement | Substantially equivalent to Arthrex BioComposite Interference Screw | Demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the mechanical and biomechanical testing. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study involved mechanical and biomechanical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for a study comparing mechanical and biomechanical properties of a medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, as this is a device clearance based on substantial equivalence for mechanical properties, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
This information is not applicable. The study is on a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth implied for the study is the established mechanical and biomechanical performance (ultimate load and cyclic displacement) of the predicate device, the Arthrex BioComposite Interference Screw.
8. The Sample Size for the Training Set
This is not applicable as the study involved mechanical and biomechanical testing of a device, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. The study involved direct mechanical and biomechanical testing and comparison to an established predicate device, not an AI training process.
§ 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.