The FiberTak Button is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular labral repair
The FiberTak Button is also 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 in the knee, shoulder, and elbow and may include the following indications; ACL/PCL repair (minor/major), biceps tendon repar and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

Device Description

The FiberTak Button is an 'all-suture' soft-tissue device constructed from a hollow braid of polyester and two shuttling sutures made of a polyblend of UHMWPE and polyester. The FiberTak Button is preloaded on a disposable inserter and will be sold sterile for single use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FiberTak Button, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device (FiberTak Button), not a clinical study report for an AI/CADe device. Therefore, many of your requested points related to AI/CADe studies (like multi-reader multi-case studies, expert consensus on images, training sets, etc.) are not applicable to this type of submission. The information below focuses on mechanical and biological performance rather than diagnostic accuracy.

Acceptance Criteria and Device Performance for FiberTak Button (K191426)

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria	Reported Device Performance
Tensile Testing	Met criteria established by predicate devices.	Demonstrated pull-out strength, including post-cyclic loading, met the criteria established by the predicate devices.
Biocompatibility	Passing results per ISO 10993-1:2009.	Demonstrated passing results per ISO 10993-1:2009.
Bacterial Endotoxin	Met pyrogen limit specifications per EP 2.6.14 / USP <85>.	Conducted to demonstrate that the device meets pyrogen limit specifications.

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

The document does not explicitly state the numerical sample sizes for the tensile testing, biocompatibility testing, or bacterial endotoxin testing. It refers to these as performance data that demonstrate equivalence.

Regarding data provenance: This clinical and regulatory document does not cover the country of origin or whether data was retrospective or prospective in the context of typical AI/CADe studies. These are laboratory and material tests.

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

This question is not applicable to the type of device and testing described. "Ground truth" in this context refers to established standards for material properties and biological response, not expert interpretation of diagnostic images. The ground truth is defined by the specified international standards (ISO 10993-1:2009, EP 2.6.14 / USP <85>) and comparison to predicate devices, which are themselves held to certain performance levels.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic imaging studies. The tests described are objective laboratory measurements, not subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the diagnostic performance of AI-assisted systems in interpreting medical images, which is not the function of the FiberTak Button.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI system was not done. The FiberTak Button is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests relies on:

Established standards and specifications: ISO 10993-1:2009 for biocompatibility, EP 2.6.14 / USP <85> for bacterial endotoxin/pyrogen limits.
Performance of legally marketed predicate devices: For tensile strength, the proposed device's performance was compared to the criteria established by its predicate devices (K181769: Arthrex FiberTak Suture Anchor, K123341: Arthrex Proximal Biceps Button). This establishes a benchmark for clinical safety and effectiveness based on prior device performance.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI algorithm being trained for this device. The term "training set" is typically used in machine learning.

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

This question is not applicable as there is no training set for an AI algorithm for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K191426

Trade/Device Name: FiberTak Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 30, 2019 Received: October 31, 2019

Dear Ms. Galmez:

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

{1}------------------------------------------------

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,

Laurence D. Coyne, Ph.D. Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191426

Device Name

FiberTak Button

Indications for Use (Describe)

The FiberTak Button is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

· Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

· Hip: Acetabular labral repair

The FiberTak Button is also 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 in the knee, shoulder, and elbow and may include the following indications; ACL/PCL repair (minor/major), biceps tendon repar and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1. 510(k) Summary

Date Prepared	November 25, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263ivette.galmez@arthrex.com
Name of Device	FiberTak Button
Common Name	Soft Tissue Fixation Device
Product Code	MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	Class II
Predicate Device	K181769: Arthrex FiberTak Suture AnchorK123341: Arthrex Proximal Biceps Button
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for theFiberTak Button.
Device Description	The FiberTak Button is an 'all-suture' soft-tissue device constructed from a hollowbraid of polyester and two shuttling sutures made of a polyblend of UHMWPE andpolyester. The FiberTak Button is preloaded on a disposable inserter and will be soldsterile for single use.
Indications for Use	The FiberTak Button is intended for fixation of suture (soft tissue) to bone in theshoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP andMCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstructionand Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital tendontransfers, Mid-foot reconstruction• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial BandTenodesis• Hip: Acetabular Labral RepairThe FiberTak Button is also used for fixation of bone to bone, or soft tissue to bone,and is intended as a fixation post, a distribution bridge, or for distributing suturetension over areas of ligament or tendon repair in the knee, shoulder, and elbow andmay include the following indications; ACL/PCL repair, Pectoralis Repair(minor/major), Biceps Tendon Repair and Reattachment (distal/proximal),Acromioclavicular Repair, and Ulnar Collateral Ligament Reconstruction.
Performance Data	Tensile testing demonstrated that the pull out strength of the proposed FiberTakButton (including post cyclic loading) met the criteria established by the predicatedevices. Biocompatibility testing per ISO 10993-1:2009 demonstrated passing results. Bacterial endotoxin per EP 2.6.14 / USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.
Conclusion	The FiberTak Button is substantially equivalent to the predicate devices in which thebasic design features and intended uses are the same. Any differences between theproposed device and the predicate devices are considered minor and do not raisequestions concerning safety or effectiveness.
	Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate devices.

{4}------------------------------------------------

Regulation Number and Section