The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle.

The Arthrex Knotless Mini TightRopes, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, the Arthrex Knotless Mini TightRopes are indicated for Carpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. The Arthrex Knotless Mini TightRopes are also indicated for use as adjuncts in the suspension of the thumb metacarpal during process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Device Description

The Arthrex Knotless Mini TightRopes are suture and button constructs that consist of two buttons, one or more suture strands and various ancillary instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM F136 (Ti-6AL-4V ELI). The sutures are manufactured from UHMWPE, polyester and/or nylon. The devices are sold sterile and are single-use.

AI/ML Overview

This document describes the Arthrex Knotless Mini TightRopes device. It appears to be a 510(k) Summary for a medical device cleared by the FDA, primarily focusing on proving substantial equivalence to predicate devices rather than providing a detailed study of its performance against specific acceptance criteria in a clinical context.

Therefore, many of the requested categories for describing an AI/device performance study and its acceptance criteria are not applicable to this document as it's a submission for a mechanical implant, not an AI or digital health device, and the "performance data" refers to mechanical testing.

However, I can extract the information that is present and indicate where information is not available or not relevant for this type of device submission.

Here's an attempt to answer your request based on the provided text, while noting the limitations:

1. A table of acceptance criteria and the reported device performance

For a mechanical implant, acceptance criteria are typically defined by demonstrating substantial equivalence to a predicate device through mechanical testing. The document states that the new device must perform "statistically equivalent" to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Ultimate Static Tensile Strength (Statistically equivalent to predicate K133275 and K061925)	"Ultimate Static Tensile... testing was conducted to demonstrate that the Arthrex Knotless Mini TightRopes perform statistically equivalent to the predicate devices cleared under K133275 and K061925." "The submitted mechanical testing data demonstrates that the ultimate tensile strength... is substantially equivalent to that of the predicate device."
Ultimate Static Shear Strength (Statistically equivalent to predicate K133275 and K061925)	"Ultimate Static Shear... testing was conducted to demonstrate that the Arthrex Knotless Mini TightRopes perform statistically equivalent to the predicate devices cleared under K133275 and K061925." "The submitted mechanical testing data demonstrates that the ultimate... shear strength... is substantially equivalent to that of the predicate device."
Cyclic Fatigue (Statistically equivalent to predicate K133275 and K061925)	"Cyclic Fatigue testing was conducted to demonstrate that the Arthrex Knotless Mini TightRopes perform statistically equivalent to the predicate devices cleared under K133275 and K061925." "The submitted mechanical testing data demonstrates that the... cyclic fatigue of the Arthrex Knotless Mini TightRopes is substantially equivalent to that of the predicate device."
MRI Safety (Meets FDA guidance and ASTM standards for MR Environment safety)	"MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance ... ASTM F2052, ASTM F2119, ASTM F2182 and ASTM F2213." "The Arthrex Knotless Mini TightRopes have been evaluated for MR Conditional labeling."
Pyrogenicity (Meets pyrogen limit specifications)	"Bacterial Endotoxins Test (BET) was performed... in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducted demonstrates that the Arthrex Knotless Mini TightRopes meet pyrogen limit specifications."
Biocompatibility (Meets ISO 10993-1:2018 for various tests)	"Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex Knotless Mini TightRopes in accordance with ISO 10993-1:2018."
No additional risks concerning sterilization and shelf-life compared to predicate due to changes	"Assessment of physical product attributes including product, design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex Knotless Mini TightRopes do not introduce additional risks or concerns regarding sterilization and shelf-life."

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: The document does not specify the exact sample sizes (e.g., number of devices tested) for the mechanical, MRI, endotoxin, or biocompatibility tests.
Data Provenance: Not explicitly stated, but these are typically laboratory tests performed by the manufacturer or contracted labs, not clinical data from a specific country or retrospective/prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The ground truth for this device is based on established engineering standards (ASTM, ISO) and comparison to predicate device performance through objective material and mechanical testing, not expert interpretation of clinical data or images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. The described tests are objective laboratory measurements.

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 is not applicable. This is a physical implant, not an AI or imaging device, and no MRMC study was conducted or is relevant to its clearance.

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

This is not applicable. This is a physical implant.

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

The "ground truth" for this device, in the context of its 510(k) clearance, is primarily defined by:

Established engineering standards (e.g., ASTM for mechanical properties and MRI safety, ISO for biocompatibility).
The performance characteristics of the legally marketed predicate devices (K133275 and K061925), which serve as the benchmark for "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

This is not applicable. See point 8.

Summary

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December 17, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Arthrex Inc. Rebecca Homan Team Lead, Regulatory Affairs 1370 Creekside Boulevard Naples. Florida 34108-5553

Re: K213644

Trade/Device Name: Arthrex Knotless Mini TightRopes Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: November 16, 2021 Received: November 18, 2021

Dear Rebecca Homan:

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

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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 (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

Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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) K213644

Device Name Arthrex Knotless Mini TightRopes

Indications for Use (Describe)

Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle.

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	December 16, 2021
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanTeam Lead, Regulatory Affairs1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex Knotless Mini TightRopes
Common Name	Button/Suture
Product Code	HTN
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class	II
Primary Predicate Device	K133275: Arthrex Mini TightRopes
Predicate Devices	K061925: Arthrex Mini TightRope Repair KitK090107: Arthrex Mini TightRope
Reference Devices	K122374: Arthrex Suture (UHMWPE)K181513: Arthrex PushLock Tenodesis AnchorK201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemK212146: Arthrex LoopLoc Knotless Suture
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex Knotless Mini TightRopes.
Device Description	The Arthrex Knotless Mini TightRopes are suture and button constructs that consist of two buttons, one or more suture strands and various ancillary instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM F136 (Ti-6AL-4V ELI). The sutures are manufactured from UHMWPE, polyester and/or nylon. The devices are sold sterile and are single-use.
Indications for Use	The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following:1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.The Arthrex Knotless Mini TightRopes, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon
	repair.
	Specifically, the Arthrex Knotless Mini TightRopes are indicated for CarpalMetacarpal (CMC) joint arthroplasty as an adjunct in the healing process ofthe thumb metacarpal by providing stabilization between the base of thefirst and second metacarpal when the trapezium has been excised due toosteoarthritis. The Arthrex Knotless Mini TightRopes are also indicated foruse as adjuncts in the suspension of the thumb metacarpal during thehealing process of hematoma distraction arthroplasty by providingstabilization at the base of the first and second metacarpal when thetrapezium has been excised due to osteoarthritis.
Performance Data	Ultimate Static Tensile, Ultimate Static Shear and Cyclic Fatigue testing wasconducted to demonstrate that the Arthrex Knotless Mini TightRopesperform statistically equivalent to the predicate devices cleared underK133275 and K061925.
	MRI force, torque, and image artifact testing were conducted in accordancewith FDA guidance Testing and Labeling Medical Devices for Safety in theMagnetic Resonance (MR) Environment, ASTM F2052 Standard Test Methodfor Measurement of Magnetically Induced Displacement Force on MedicalDevices in the Magnetic Resonance Environment, ASTM F2119 Standard TestMethod for Evaluation of MR Image Artifacts from Passive Implants, ASTMF2182 Standard Test Method for Measurement of Measurement of RadioFrequency Induced Heating Near Passive Implants During MagneticResonance Imaging and ASTM F2213 Standard Test Method forMeasurement of Magnetically Induced Torque on Medical Devices in theMagnetic Resonance Environment.
	Bacterial Endotoxins Test (BET) was performed on the Arthrex Knotless MiniTightRopes utilizing the Kinetic Chromogenic Method in accordance withANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testingconducted demonstrates that the Arthrex Knotless Mini TightRopes meetpyrogen limit specifications.
	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterizationtesting was conducted on the Arthrex Knotless Mini TightRopes inaccordance with ISO 10993-1:2018.
	Assessment of physical product attributes including product, design, size,and materials as well as the conditions of manufacture and packaging hasdetermined that the Arthrex Knotless Mini TightRopes do not introduceadditional risks or concerns regarding sterilization and shelf-life.
TechnologicalComparison	The Arthrex Knotless Mini TightRopes are substantially equivalent to thepredicate devices cleared under K133275 in which the intended use,fundamental scientific technology, sterility, shelf life, basic design featuresand configurationare identical.
	The buttons within the Arthrex Knotless Mini TightRopes will bemanufactured from Titanium conforming to ASTM F136 (Ti-6AL-4V ELI);whereas the buttons within the predicate devices cleared under K133275 are

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	manufactured from Stainless Steel conforming to ASTM F138.
	In addition to the 4-Hole Round and 2-Hole Oblong buttons, the Arthrex Knotless Mini TightRopes contain Slotted Oblong and Dual-Fixation buttons; whereas the buttons within the predicate devices cleared under K133275 contain the 4-Hole Round and 2-Hole Oblong buttons.
	The suture within the proposed Arthrex Knotless Mini TightRopes will be manufactured from UHMWPE, Polyester and/or Nylon; whereas the suture within the predicate devices cleared under K133275 are manufactured from UHMWPE and Polyester.
	The Arthrex Knotless Mini TightRopes will be packaging in a double Tyvek blister configuration; whereas the predicate devices cleared under K133275 are packaged in a double Tyvek/poly pouch configuration.
	The Arthrex Knotless Mini TightRopes have been evaluated for MR Conditional labeling; whereas the predicate devices cleared under K133275 were not evaluated for MR Conditional labeling.
	The Arthrex Knotless Mini TightRopes are a line extension to the predicate devices, which include minor dimensional modifications with no change to intended use or function. Any differences between the Arthrex Knotless Mini TightRopes and the predicate devices are considered minor and do not raise different questions of safety or effectiveness.
Conclusion	The Arthrex Knotless Mini TightRopes are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.
	The submitted mechanical testing data demonstrates that the ultimate tensile strength, ultimate shear strength and cyclic fatigue of the Arthrex Knotless Mini TightRopes is substantially equivalent to that of the predicate device for the desired indications.
	Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device.

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.