Arthrex FiberTak Anchors by Arthrex, Inc.

The Arthrex Fiber Tak Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

• 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, Repair/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

Device Description

The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair.

The FiberTak anchor is constructed from a hollow braid of polyester with a suture component assembled through the hollow braid. The suture component can be comprised of UHWMPE or a polyblend of UHMWPE and Polyester. The anchor comes preloaded on a disposable inserter made from surgical grade nitinol and ABS plastic. The Arthrex FiberTak Anchors may be sold separately or in a kit with implantation instrumentation. The Arthrex FiberTak Anchors are provided sterile for single use.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrex FiberTak Anchors. This documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria in the way one might for an AI/ML or diagnostic device.

Therefore, the information required to populate most of the sections regarding acceptance criteria, study design, expert ground truth, and training data for an AI/ML device is not present in this document. The document primarily describes physical and functional characteristics and provides performance data in comparison to a predicate device.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Pull-out strength meets or exceeds predicate device.	The submitted mechanical testing demonstrates that the pull-out strength of the proposed Arthrex FiberTak Anchors meet or exceed the pull out strength of the predicate device.
Pull-out displacements meet predicate criteria.	The pull out displacements recorded were found to meet the criteria established by the predicate devices and therefore of no clinical relevance.
Biocompatibility of new suture component is acceptable.	Biocompatibility for the new suture component was reviewed and determined to be acceptable due to its similarities in material.
Packaging/shelf life of new suture component is acceptable.	Packaging/shelf life for the new suture component was reviewed and determined to be acceptable due to its similarities in packaging.

Note: The document states "meet or exceed" and "determined to be acceptable," but does not provide the specific numerical values for the predicate device's pull-out strength or acceptable displacement range that were used as benchmarks.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified. The document mentions "submitted mechanical testing" but does not detail the sample size or provenance of the test data (e.g., how many anchors were tested, where the tests were performed).
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)
Not applicable/Not specified. This device is a physical fixation device, not a diagnostic or AI/ML device that requires expert-established ground truth for its performance evaluation in the traditional sense. Its performance is evaluated through mechanical bench testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation or AI output in diagnostic studies, which is not the case here.
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 medical device for tissue fixation, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device; there is no algorithm or 'standalone' performance in that context. The "standalone" performance would be its mechanical properties, which were tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" is established by objective, measurable mechanical properties (e.g., loads, displacements) determined through standardized laboratory testing procedures. It's not a ground truth derived from expert consensus, pathology, or outcomes data in the usual sense for diagnostic products. The comparison is against the predicate device's established performance properties.
The sample size for the training set
Not applicable/Not specified. This is a physical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established
Not applicable. Refer to point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.

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

June 19, 2015

Arthrex, Incorporated Ms. Ivette Galmzez Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K151230

Trade/Device Name: Arthrex FiberTak Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: May 20, 2015 Received: May 21, 2015

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. 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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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151230 Device Name

Arthrex FiberTak Anchors

Indications for Use (Describe)

The Arthrex Fiber Tak Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

· 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 PP, 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 Repart, 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

2 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

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	June 19, 2015
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Ivette GalmezRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71263Fax: 239/598.5508Email: igalmez@arthrex.com
Trade Name	Arthrex FiberTak Anchors
Common Name	Soft Tissue Fixation Device
Product Code -Classification NameCFR	MBIFastener, fixation, nondegradable, soft tissue21 CFR 888.3040
Predicate Device	K140476: Arthrex FiberTak Suture Anchor
Purpose of Submission	This special 510(k) premarket notification is submitted to obtainclearance for the Arthrex FiberTak Anchors. The Arthrex FiberTakAnchors include modifications to predrilling instructions anddrilling instruments, new double loaded configurations and newsuture components.
Device Description	The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixationdevices with an expandable push-in design. The anchor andconnected sutures are impacted into a pilot hole. The sutures arethen manually tensioned to set the anchor by "bulging" thesuture sleeve within the pilot hole. Once the anchor is set, thesuture is passed around the soft tissue and tied in a knot tocomplete the repair.
	The FiberTak anchor is constructed from a hollow braid ofpolyester with a suture component assembled through thehollow braid. The suture component can be comprised ofUHWMPE or a polyblend of UHMWPE and Polyester. The anchorcomes preloaded on a disposable inserter made from surgicalgrade nitinol and ABS plastic. The Arthrex FiberTak Anchors maybe sold separately or in a kit with implantation instrumentation.The Arthrex FiberTak Anchors are provided sterile for single use.
Intended Use	The Arthrex FiberTak Anchors are intended to be used for sutureor tissue fixation in the foot/ankle, knee, hand/wrist, elbow, andshoulder. Specific indications are listed below:
	• Elbow: Biceps Tendon Reattachment, Ulnar or Radial CollateralLigament Reconstruction
	• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift or CapsulolabralReconstruction
	• Hand/Wrist: Scapholunate Ligament Reconstruction,Repair/Reconstruction of collateral ligaments, Repair of Flexorand Extensor Tendons at the PIP, DIP and MCP joints for alldigits, digital tendon transfers, Carpal Ligament Reconstructionand Carpometacarpal joint arthroplasty (basal thumb jointarthroplasty)
	• Foot/Ankle: Lateral Stabilization, Medial Stabilization, AchillesTendon Repair, Metatarsal Ligament Repair, Hallux Valgusreconstruction, digital tendon transfers, Mid-footreconstruction
	• Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band Tenodesis
Substantial EquivalenceSummary	The proposed Arthrex FiberTak Anchors are similar to thepredicate device, in which the basic design features, materialsand intended uses are the same.
	The submitted mechanical testing demonstrates that the pull-outstrength of the proposed Arthrex FiberTak Anchors meet orexceed the pull out strength of the predicate device. In addition,the pull out displacements recorded were found to meet thecriteria established by the predicate devices and therefore of noclinical relevance. Furthermore, the biocompatibility andpackaging/shelf life for the new suture component werereviewed and determined to be acceptable due to its similaritiesin material and packaging.
	Based on the indication for use, the technological characteristics,and the summary of data submitted, Arthrex, Inc. hasdetermined that the Arthrex FiberTak Anchors is substantiallyequivalent to currently marketed predicate devices.

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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.