(46 days)
The Arthrex TightRope II devices are intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
The Arthrex TightRope II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with holes to permit suture passage and assembly with Arthrex sutures.
This document is a 510(k) premarket notification for a medical device called the "Arthrex TightRope II". It details the submission to the FDA for expanding the indications for use of this device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:
Crucially, the provided document DOES NOT contain the type of detailed information typically found for the evaluation of AI/ML-based medical devices or diagnostic tools. This document is for a mechanical fixation device (a bone/soft tissue fastener). Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," "ground truth establishment by experts" etc., are not applicable to this type of device submission.
The "Performance Data" section in the document clearly states: "Based on cyclic displacement and strength testing, the proposed Arthrex TightRope II device is equivalent to the predicate Zimmer-Biomet ToggleLoc™ device." This indicates the device's performance was evaluated through mechanical testing, not through clinical studies involving expert interpretation of images or AI algorithm performance.
Given this context, I will address the relevant parts of your request based on the information available in the provided document and explicitly state where the requested information is not applicable.
Device Name: Arthrex TightRope II
Type of Device: Smooth or Threaded Metallic Bone Fixation Fastener
Purpose of Submission: Expand device indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical fixation device, the "acceptance criteria" are related to mechanical properties and equivalence to a predicate device, not diagnostic performance metrics.
| Acceptance Criteria (Implied from "Performance Data") | Reported Device Performance |
|---|---|
| Mechanical Equivalent to Predicate Device | Demonstrated equivalence to the predicate Zimmer-Biomet ToggleLoc™ device based on cyclic displacement and strength testing. This equivalence supports the proposed expanded indications for soft tissue repairs and reconstructions in the knee. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of devices tested, but the evaluation methods are described as "cyclic displacement and strength testing." This implies testing a sufficient number of physical devices or components to establish mechanical properties.
- Data Provenance: The tests were conducted internally by Arthrex Inc. or a contracted lab. No specific country of origin for data (as in patient data) is relevant here, as it's a mechanical device study. It's a proprietary test conducted by the manufacturer to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a mechanical device, not a diagnostic or AI device requiring expert interpretation for ground truth. The "ground truth" here is the established mechanical performance standards and equivalence to the predicate device, determined through material science and engineering testing.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Mechanical testing does not involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic imaging systems evaluated with human readers, often with AI assistance. It is not applicable to a mechanical bone fixation fastener.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This refers to the standalone performance of an AI algorithm. It is not applicable to this mechanical device.
7. The Type of Ground Truth Used
- Mechanical Performance Standards & Predicate Equivalence: The "ground truth" for this device's performance evaluation is its mechanical behavior (e.g., strength, displacement under load) as measured against engineering standards and in comparison to the well-established predicate device (Zimmer-Biomet ToggleLoc™).
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of AI/machine learning. Its design and validation rely on engineering principles, materials science, and mechanical testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of the study that proves the device meets acceptance criteria:
The study proving the device meets its acceptance criteria involved mechanical testing, specifically "cyclic displacement and strength testing." The goal was to establish "equivalence" of the proposed Arthrex TightRope II device to the predicate device, Zimmer-Biomet ToggleLoc™. This type of testing assesses the physical properties and performance characteristics of the implantable medical device under simulated physiological conditions. The manufacturer, Arthrex Inc., performed these tests to demonstrate that the expanded indications for use (MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population) are supported by the device's equivalent mechanical performance to a device already cleared for similar applications.
§ 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.