Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II by Arthrex Inc.

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 <85>.	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."

Summary

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October 5, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K221128

Trade/Device Name: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: April 14, 2022 Received: April 18, 2022

Dear Lai Saeteurn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For:

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221128

Device Name Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared	October 5, 2022
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Lai SaeteurnRegulatory Affairs Specialist II1-239-598-4302, ext. 71764Lai.Saeteurn@Arthrex.com
Name of Device	Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Common Name	Smooth or threaded metallic bone fixation fastener
Product Code	MAI – Single/Multiple component metallic bone fixation appliances and accessoriesMBI – Smooth or threaded metallic bone fixation fastener
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fastener21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class	II
Predicate Device	K202581: Arthrex TightRope IIK112990: ACL TightRopeK110123: PCL TightRope
Reference Device	K130217: Orthopediatrics ACL Reconstructive SystemK201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain pediatric indications for the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices cleared under K112990, K110123, and K202581.
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.
Comparison Summary of Technological Characteristics and Modifications Proposed	The proposed devices have the same technological characteristics (device design, material, sterilization method, and biocompatibility profile). The proposed device modification is the addition of the pediatric patient population.The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are substantially equivalent to the predicate device in which the design features and intended uses are the same. Any differences between the proposed device and the predicate devices are considered minor and do not result in new or different questions concerning safety or effectiveness
Indications for Use	The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices areintended to be used for fixation of bone to bone or soft tissue to bone, and areintended as fixation posts, a distribution bridge, or for distributing suturetension over areas of ligament or tendon repair. Specifically, Arthrex will beoffering these devices for ACL/PCL repair and reconstruction for the adult andpediatric patient population.
Performance Data	Ultimate load testing and cyclic displacement was performed on the proposeddevices and compared to the predicate device. The test results demonstratethat the proposed and predicate devices are equivalent.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstratethat the device meets pyrogen limit specifications.
Clinical Literature	Clinical literature was provided on the subject devices involving the proposedpatient population of pediatric patients. The reviewed literature shows thedevice is effective when used in the proposed patient population.
Real WorldData/Evidence	Real World Data/evidence is provided from the Surgical Outcomes Systemregistry. Based on the patient outcomes, there are no statistical differences inpatients less than 22 years of age versus patients greater than 22 years of age.
Conclusion	The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices aresubstantially equivalent to the predicate devices in which the basic designfeatures and intended use are the same. Any differences between theproposed device and the predicate devices are considered minor and do notresult in new or different questions concerning safety or effectiveness. Basedon the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex has determined that the proposed devices aresubstantially equivalent to the currently marketed predicate device.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.