The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

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

Device Description

The Arthrex Knotless FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. It is constructed from a hollow braid of polyester. An UHMWPE suture construct is assembled through the hollow braid coupled with a nitinol passing wire. The device comes preloaded on a disposable inserter.

AI/ML Overview

Here's an analysis of the provided text regarding the Arthrex Knotless FiberTak Suture Anchor, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: Arthrex Knotless FiberTak Suture Anchor

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary indicates that the primary acceptance criterion is substantial equivalence to predicate devices. This means the new device must perform comparably to existing, legally marketed devices for its intended use.

Specifically, the document states:

Acceptance Criteria	Reported Device Performance
Basic Design Features are the same as predicate devices.	"The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same."
Intended Uses are the same as predicate devices.	"The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same." (Specific intended uses for various anatomical locations are listed in detail for the device itself, implying they align with the uses of the predicate devices).
Material Composition is substantially equivalent to predicate devices.	"The proposed devices are comprised of polyester and UHMWPE. These materials are substantially equivalent to the materials found in the predicate devices."
Tensile Strength (pull-out) is substantially equivalent to predicate devices for the desired indications.	"The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications."
Safety and Effectiveness are not compromised by any minor differences.	"Any differences between the Arthrex Knotless FiberTak and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This is a general statement that encompasses the overall assessment of the device's performance relative to the predicates.

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

The document explicitly mentions "mechanical testing data" to demonstrate tensile strength (pull-out). However, it does not specify the sample size used for this mechanical testing.

The data provenance is implied to be from laboratory-based mechanical testing, likely conducted by Arthrex, Inc. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of mechanical testing for a medical device, it would inherently be prospective in its execution (i.e., tests were performed specifically for this submission).

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

The concept of "ground truth" established by experts, as typically applied in AI/ML studies, is not applicable here. This document describes the premarket notification for a physical medical device (suture anchor), not a diagnostic algorithm or AI system. The "truth" or performance is established through direct mechanical testing, not through expert interpretation of data.

4. Adjudication Method for the Test Set

Since ground truth as per AI/ML context is not applicable, an adjudication method in that sense is not relevant for this mechanical device submission. The results of the mechanical tests themselves would be the "data" that are then compared against the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI systems, particularly how human readers perform with or without AI assistance. This submission is for a physical surgical anchor.

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) was not done. This is not an AI/ML device. The "standalone performance" here would be the tensile strength and other mechanical properties of the device itself, which were indeed tested.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on objective mechanical testing data, specifically "tensile strength (pull-out)." This is a direct physical measurement, not expert consensus, pathology, or outcomes data. The comparison is made against documented performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This is not an AI/ML device that requires a training set for model development. The device itself is being tested, not an algorithm.

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

As there is no training set for an AI/ML model, this question is not applicable.

Summary

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・

MAY 3 2013

Administes 510(K): ARTHREX KNOTLESS FIBERTAK SUTURE ANCHOR

2 510(k) Summary of Safety and Effectiveness

Date Summary Prepared	February 15, 2013
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Christina FloresRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239-643-5553, ext. 1819Fax: 239-569-5508Email: Christina.flores@arthrex.com
Trade Name	Knotless FiberTak Suture Anchor
Common Name	Soft Tissue Fixation Device
Product Code	MBI
Classification Name	Fastener, fixation, nondegradable, soft-tissue
CFR	21 CFR 888.3040
Predicate Device	K120155: Arthrex Knotless SutureTakK041553: Arthrex FiberWireK110145 Biomet JuggerKnotTM Soft Anchors
Purpose of Submission	This traditional 510(k) premarket notification is submitted toobtain clearance for the Arthrex Knotless FiberTak SutureAnchor, to expand the Arthrex SutureTak family of anchors.
Device Description and IntendedUse	The Arthrex Knotless FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-indesign. It is constructed from a hollow braid of polyester. AnUHMWPE suture construct is assembled through the hollowbraid coupled with a nitinol passing wire. The device comespreloaded on a disposable inserter.The Arthrex Knotless FiberTak is intended for fixation in thefoot, ankle, knee, hand, wrist, elbow, shoulder, and hip.Specific indications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or RadialCollateral Ligament ReconstructionShoulder: Rotator Cuff Repairs, Bankart Repair, SLAPLesion Repair, Biceps Tenodesis, Acromio-Clavicular

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Arthrex 510(K): ARTHREX KNOTLESS FIBERTAK SUTURE ANCHOR

	Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist :	Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments; Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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
Substantial Equivalence Summary	The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same. Any differences between the Arthrex Knotless FiberTak and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
	The proposed devices are comprised of polyester and UHMWPE. These materials are substantially equivalent to the materials found in the predicate devices.
	The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications.
	Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Knotless FiberTak Suture Anchor is substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K130458

Trade/Device Name: Arthrex Knotless FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code: MBI Dated: April 22, 2013 Received: April 24, 2013

Dear Ms. Flores:

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. 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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christina Flores

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin.D.Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form 1

Indications for Use

K130458 510(k) Number (if known):

Arthrex Knotless FiberTak Suture Anchor Device Name:

Indications For Use:

The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction
Shoulder:	Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction
Hand/Wrist:	Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions,Repair/Reconstruction of collateral ligaments, Repair of Flexor and ExtensorTendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, MetatarsalLigament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip:	Acetabular Labral repair

Prescription Use V AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE I of I

Image /page/4/Picture/12 description: The image contains the text "Casey L-Hanley, Ph.D Division of Orthopedic Devices". The text is arranged in a way that suggests it might be a title or heading, possibly related to a document or report. The presence of "Ph.D" indicates an academic or professional context.

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.