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The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation 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.

Device Description

The Arthrex ACL TightRope®, PCL TightRope®, and 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.

The proposed devices are available in various device models referred to as TightRope® ABS, Implant; TightRope®, PCL; ACL TightRope® RT; ACL TightRope® II RT; ACL TightRope® II RT, Double Loaded Passing Sutures; BTB TightRope® II; BTB TightRope® II, Double Loaded Passing Sutures; and TightRope® II ABS, Implant Open.

AI/ML Overview

This document describes the 510(k) premarket notification for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices, seeking to expand their indications to include the pediatric patient population. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices for this new patient group.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Ultimate Load Testing	Proposed devices must be equivalent to the predicate device.	The test results demonstrate that the proposed and predicate devices are equivalent.
Cyclic Displacement	Proposed devices must be equivalent to the predicate device.	The test results demonstrate that the proposed and predicate devices are equivalent.
Bacterial Endotoxin (Pyrogen)	Device must meet pyrogen limit specifications as per EP 2.6.14/USP .	Pyrogen testing was conducted, demonstrating that the device meets pyrogen limit specifications.
Clinical Effectiveness (Pediatric)	Device must be effective when used in the proposed pediatric patient population.	Clinical literature reviewed shows the device is effective when used in the pediatric patient population.
Real-World Outcomes (Pediatric)	No statistical differences in outcomes between patients less than 22 years of age and those greater than 22 years of age.	Real-world data from the Surgical Outcomes System registry shows no statistical differences in patient outcomes between those less than 22 years of age versus those greater than 22 years of age.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of an AI/ML device where performance metrics like sensitivity, specificity, etc., are usually evaluated on a separate test set. Instead, the provided information relates to:

Mechanical Testing (Ultimate Load & Cyclic Displacement): The sample sizes for these tests are not explicitly stated in the summary but generally involve a specific number of devices/constructs for each test condition.
Clinical Literature Review: This involves reviewing existing clinical studies, so the "sample size" is the cumulative number of patients across all included studies. The provenance is "clinical literature" implying published research.
Real-World Data/Evidence: Derived from the "Surgical Outcomes System registry." The country of origin is not specified, but registries often collect data from multiple institutions, potentially spanning different regions. This is retrospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The submission is for a medical device (fixation appliances) and not an AI/ML diagnostic or predictive algorithm that relies on expert-established ground truth for its performance evaluation for this specific 510(k) submission. The "ground truth" for mechanical tests is defined by engineering specifications and physical measurements. For clinical effectiveness, it's defined by patient outcomes in surgical settings described in clinical literature and registries.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring human adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This 510(k) submission is for a mechanical surgical fixation device, not an AI-assisted diagnostic or imaging device that would typically involve MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Mechanical Testing (Ultimate Load & Cyclic Displacement): The ground truth is based on the physical properties and performance characteristics measured according to established engineering and biomechanical testing standards.
Clinical Literature: The ground truth is clinical outcomes and effectiveness observed in human patients as reported in peer-reviewed medical literature.
Real-World Data/Evidence: The ground truth is patient outcomes recorded in a surgical registry.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML algorithm that employs a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. This is not an AI/ML algorithm that employs a "training set."

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K Number

K110123

Device Name

PCL TIGHTROPE

Manufacturer

ARTHREX, INC.

Date Cleared

2011-04-28

(100 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K071176,K100652

Intended Use

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.

Device Description

The proposed PCL TightRope consists of an adjustable non-absorbable suture loop, and 2 titanium buttons.

AI/ML Overview

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.

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