Arthrex TightRope II by Arthrex Inc.

The Arthrex TightRope II is intended to be used for fixation of 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. Specifically, Arthrex will be offering these for ACL/PCL Repair and Reconstruction.

Device Description

The Arthrex TightRope II is suture and button construct comprised of a titanium button and nonabsorable suture intended to be used for the purpose ACL/PCL repair and reconstruction.

AI/ML Overview

This is a 510(k) summary for a medical device, which means it describes the device and its equivalence to a predicate device, but it does not contain information about an AI/ML-driven medical device or a clinical study proving its performance against acceptance criteria in the way a diagnostic AI would.

The document describes the Arthrex TightRope II, which is a mechanical device (suture and button construct) for bone and soft tissue fixation, specifically for ACL/PCL repair and reconstruction.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance for this type of mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

For the Arthrex TightRope II, the "acceptance criteria" are implied by demonstrating that modifications to the device (compared to its predicate) do not negatively impact its mechanical strength and that it meets pyrogen limits and MR compatibility standards.

Performance Metric	Acceptance Criteria (Implied/Standard)	Reported Device Performance and Method
Mechanical Strength	Modifications do not negatively impact mechanical strength compared to predicate device K112990.	Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (Specific quantitative results are not provided in this summary but are implied to meet equivalence.)
Pyrogenicity	Meets pyrogen limit specifications (per EP 2.6.14/USP <85>).	Bacterial endotoxin testing per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Specific quantitative results are not provided but are implied to meet the standard.)
MR Safety & Compatibility	Meets FDA guidance and ASTM standards for MR compatibility (i.e., safe for use in MR environment).	MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and specific ASTM standards: - ASTM F2052 (Magnetically Induced Displacement Force)- ASTM F2119 (MR Image Artifacts)- ASTM F2182 (Radio Frequency Induced Heating)- ASTM F2213 (Magnetically Induced Torque) (Results are not quantified but are implied to show MR conditional labeling is appropriate and safe.)

Explanation of the Study Proving Device Meets Acceptance Criteria:

The study involved various bench tests and laboratory analyses comparing the Arthrex TightRope II to its predicate device (K112990) and assessing its compliance with relevant regulatory standards. These tests covered:

Mechanical Performance: Ultimate load testing and cyclic displacement testing to ensure the device's structural integrity and durability were not compromised by design modifications.
Biocompatibility/Pyrogenicity: Bacterial endotoxin testing to confirm the device is non-pyrogenic.
MR Compatibility: A series of tests adhering to FDA guidance and ASTM standards (F2052, F2119, F2182, F2213) to evaluate magnetic force, torque, radiofrequency-induced heating, and image artifacts, leading to an "MR conditional" label.

The conclusion states that these "performance data" demonstrate that the device modifications are minor and "do not raise different questions concerning safety or effectiveness," thereby supporting its substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This document does not specify the number of individual devices or test runs for each mechanical or biological test. These are typically standard laboratory tests, not clinical studies with patient data.
Data Provenance: The data would originate from laboratory bench testing and analysis conducted by the manufacturer (Arthrex Inc.) or a contracted testing facility, likely in the US, as Arthrex Inc. is based in Naples, FL, USA. It is essentially prospective testing against predefined engineering and material standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a mechanical fixation device, "ground truth" is established by adherence to engineering specifications, material science principles, and regulatory standards, not by expert medical review of patient data. The "experts" involved would be engineers, material scientists, and quality assurance specialists performing the tests and comparing results to established benchmarks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is not a diagnostic AI study requiring adjudication of expert opinions. Device performance is determined by quantitative measurements against objective criteria.

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

Not Applicable. This is a mechanical surgical device, not an AI-driven diagnostic or assistive tool for human readers.

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

Not Applicable. This device is a mechanical construct, not an algorithm. Its performance is inherent in its physical and material properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: For mechanical performance, the "ground truth" is defined by engineering specifications, material properties, and established industry standards (e.g., maximum load, displacement limits, pyrogen limits, MR safety thresholds from ASTM standards).

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this mechanical device.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question does not apply.

Summary

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November 4, 2020

Kelsey Roberts Regulatory Affairs Associate Specialist Arthrex Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K202581

Trade/Device Name: Arthrex TightRope II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: September 3, 2020 Received: September 8, 2020

Dear Ms. Roberts:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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,

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) K202581

Device Name Arthrex 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	November 3, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Kelsey N. RobertsRegulatory Affairs Associate Specialist1-239-643-5553, ext. 72257Kelsey.Roberts@arthrex.com
Name of Device	Arthrex TightRope II
Common Name	Smooth or threaded metallic bone fixation fastener
Product Code	MBI - Smooth or threaded metallic bone fixation fastener.HTN – Single/multiple component metallic bone fixation appliances and accessories
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K112990: ACL TightRope and ACL TightRope Double Bundle
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex TightRope II as a line extension to the Arthrex TightRope devices clearedunder K112990.
Device Description	The Arthrex TightRope II is suture and button construct comprised of a titaniumbutton and nonabsorable suture intended to be used for the purpose ACL/PCL repairand reconstruction.
Indications for Use	The Arthrex TightRope II is to be used for fixation of bone to bone or soft tissue tobone, and are intended as fixation posts, a distribution bridge, or for distributingsuture tension over areas of ligament or tendon repair. Specifically, Arthrex will beoffering these for ACL/PCL repair and reconstruction.
Comparison Summaryof TechnologicalCharacteristic andModificationsProposed	The proposed and predicate devices (K112990) have the same intended use and basicdevice design features. The proposed device modifications consist of button design,button manufacturing, implantable suture design, and the addition of MR conditionallabeling. The sterilization method, packaging, and button size is identical to thepredicate (K112990).The Arthrex TightRope II is substantially equivalent to the predicate device in whichthe basic design features and intended uses are the same. Any differences betweenthe proposed device and the predicate device are considered minor and do not raisedifferent questions concerning safety or effectiveness.
Performance Data	Ultimate load testing and cyclic displacement was performed on the subject deviceand compared to the predicate device to demonstrate that the modifications do notnegatively impact mechanical strength.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.MRI force, torque, and image artifact testing were conducted in accordance with FDAguidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance(MR) Environment, ASTM F2052 Standard Test Method for Measurement ofMagnetically Induced Displacement Force on Medical Devices in the MagneticResonance Environment, ASTM F2119 Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants, ASTM F2182 Standard Test Method forMeasurement of Measurement of Radio Frequency Induced Heating Near PassiveImplants During Magnetic Resonance Imaging and ASTM F2213 Standard Test
	Method for Measurement of Magnetically Induced Torque on Medical Devices in theMagnetic Resonance Environment.
Conclusion	The Arthrex TightRope II is substantially equivalent to the predicate device in whichthe basic design features and intended use are the same. Any differences betweenthe Arthrex proposed device and the predicate device are considered minor and donot raise questions concerning safety and effectiveness. Based on the indications foruse, technological characteristics, and the summary of data submitted, Arthrex Inc.has determined that the proposed device is substantially equivalent to the currentlymarketed predicate device.

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Regulation Number and Section

§ 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.