The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:

· Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
· Sternotomy indications including the "rewiring" of osteotomized sternums.
· Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
· Repair of long bone fractures due to trauma or reconstruction.

Device Description

The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.

However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:

Performance Aspect (Implicit Acceptance Criterion)	Reported Device Performance
Fatigue Strength	Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System.
Tensile Force	Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System.
Creep	Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System.
Knot Strength	Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System.
Wear Testing with Particle Analysis	Demonstrated no statistical significant differences between the proposed Arthrex FiberTape Cerclage and the cleared DSM Biomedical DPR Cable.
Bacterial Endotoxins Test (Pyrogenicity)	Performed in accordance with USP <85> and demonstrated that the device meets pyrogen limit specifications. (This implies it passed the limits set by USP <85>).
Biocompatibility	Not explicitly detailed in this section, but is generally required for medical devices. The document implies it's covered by substantial equivalence to predicates using similar materials.
Material Composition	Braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials, identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374).

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

The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).

Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.

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

This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).

4. Adjudication Method for the Test Set

This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The results are quantitative 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. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant to this submission.

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

This is not applicable. As stated in point 5, this is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.

For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP <85>.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.

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

This is not applicable as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of human figures. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text.

November 15, 2017

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

Re: K170206

Trade/Device Name: Arthrex FiberTape Cerclage Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: October 18, 2017 Received: October 19, 2017

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 Mav 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

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

510(k) Number (if known) K170206

Device Name

Arthrex FiberTape Cerclage

Indications for Use (Describe)

· Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
· Sternotomy indications including the "rewiring" of osteotomized sternums.
· Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
· Repair of long bone fractures due to trauma or reconstruction.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary 1.

Date Prepared	November 13, 2017
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263lvette.galmez@arthrex.com
Name of Device	Arthrex FiberTape Cerclage
Common Name	Bone Fixation Cerclage, Suture
Product Code	JDQ, GAT
Classification Name	21 CFR 888.3010: Bone Fixation Cerclage21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture
Regulatory Class	ll
Predicate Device	K143716: DSM Biomedical DPR Cable
Reference Predicate	K102834: ISO-Elastic Cerclage SystemK032245: Arthrex FiberTape FamilyK041553: Arthrex Suture Grafting KitK122374: Arthrex Suture
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex FiberTape Cerclage sutures for use as bone fixation cerclage. This ArthrexFiberTape Cerclage submission is comprised of four suture devices, two of which(FiberTape® and TigerTape™) have been previously cleared in K032245, K041553 andK122374.
Device Description	The Arthrex FiberTape Cerclage suture is available as a flat braided suture orassembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braidedfrom a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) andpolyester materials identical to those used in other cleared Arthrex sutures (K032245,K041553 and K122374). For the loop assembly, the looped end of the suture is tied asa hitch over a sheath that secures a double looped suture.
Intended Use	The Arthrex FiberTape Cerclage suture is intended for use in soft tissueapproximation and or ligation. These sutures may be incorporated, as components,into surgeries where constructs including those with allograft or autograft tissues areused for repair. When used as bone fixation cerclage the suture is intended for:• Trochanteric reattachment after trochanteric osteotomy following total hiparthroplasty• Sternotomy indications including the "rewiring" of osteomized sternums· Trauma surgery indications including olecranon, ankle, patella and some shoulderfracture rewiring• Repair of long bone fractures due to trauma or reconstruction
Substantial EquivalenceSummary	The Arthrex FiberTape Cerclage suture is substantially equivalent to the predicatedevices, in which the basic design features and intended uses are the same. Anydifferences between the Arthrex FiberTape Cerclage and the predicates are consideredminor and do not raise new questions concerning safety and effectiveness.
	The submitted testing data, fatigue strength, tensile force, creep and knot strengthdemonstrates that the Arthrex FiberTape Cerclage is substantially equivalent to thecleared DSM Biomedical DPR Cable and the Kinamed ISO-Elastic Cerclage System.Wear testing with particle analysis and comparative testing demonstrated nostatistical significant differences between the proposed Arthrex FiberTape Cerclageand the cleared DSM Biomedical DPR Cable.
	Bacterial Endotoxins Test was performed in accordance to USP <85> to demonstratethat the device meets pyrogen limit specifications.
	Based on the indication for use, the technological characteristics, and the summary ofdata submitted, Arthrex, Inc. has determined that the Arthrex FiberTape Cerclagesuture is substantially equivalent to currently marketed predicate devices.

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K170206 - Page 2 of 2

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.