Arthrex Radiopaque FiberTape cerclage sutures are 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 bone fixation cerclage the sutures are intended for:
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• Sternotomy indications including the “rewiring” of osteomized sternums
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring

Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• Repair of long bone fractures due to trauma or reconstruction

Device Description

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures assembled on an ABS loader. The Radiopaque FiberTape Cerclage implant is hitched around the post of the ABS loader which allows the nitinol wire to pass through the knot. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and polyester materials.

AI/ML Overview

This document pertains to the 510(k) premarket notification for Arthrex Radiopaque FiberTape Cerclage sutures, a medical device. The information provided outlines the regulatory clearance and briefly mentions performance data, but it does not contain the detailed study information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, or the methodologies for ground truth establishment or MRMC studies that would be typically found in a clinical study report for an AI/ML-based device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about MRMC studies, standalone algorithm performance, or detailed ground truth establishment as these details are not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, and general performance testing (tensile strength, cyclic displacement, creep displacement, and bacterial endotoxin testing), rather than a clinical study demonstrating AI performance.

Here's what can be extracted and what cannot:

What can be extracted from the document:

Device Name: Arthrex Radiopaque FiberTape Cerclage sutures
Intended Use: Soft tissue approximation and/or ligation, and as bone fixation cerclage for specific indications (e.g., trochanteric reattachment, sternotomy, trauma, glenoid bone loss, long bone fractures).
Basis for Clearance: Substantial Equivalence to predicate devices (K221485: Arthrex FiberTape and TigerTape Cerclage Sutures and K143716: DSM Biomedical DRP Cable).
Performance Data Mentioned (not detailed acceptance criteria):
- Tensile strength
- Cyclic displacement
- Creep displacement
- Bacterial Endotoxins Test (BET) per EP 2.6.14/USP <85> to meet pyrogen limit specifications. This is a sterility/biocompatibility test, not a performance metric for the device's functional use in approximating tissue or fixing bone in a clinical context.

What cannot be extracted from the document (as it's not present):

A table of acceptance criteria and the reported device performance (in the context of clinical or AI performance): The document mentions "performance data" but only lists types of mechanical/biocompatibility tests. It does not provide specific acceptance criteria values (e.g., "tensile strength > X N") or the measured performance values from these tests. Critically, there's no mention of performance criteria relevant to an AI/ML device (e.g., sensitivity, specificity, AUC).
Sample size used for the test set and the data provenance: Not mentioned. The performance data mentioned (tensile, cyclic, creep, BET) would have sample sizes, but these are for material properties, not for a clinical evaluation or an AI model's test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/ML imaging device that would require expert-established ground truth for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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/not mentioned. This is a physical medical device (suture), not an AI/ML system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned in the context of an AI/ML model.
The sample size for the training set: Not applicable/not mentioned. There is no AI model involved.
How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion:

The provided FDA letter and 510(k) summary are for a conventional medical device (sutures), not an AI/ML-driven device. Therefore, the detailed information typically associated with acceptance criteria and study designs for validating AI/ML performance (e.g., test/training set sizes, expert ground truth, MRMC studies) is not present in this document. The "performance data" mentioned refers to mechanical and biocompatibility testing of the suture materials, which are relevant for a physical device's safety and effectiveness compared to a predicate.

Summary

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August 24, 2023

Arthrex, Inc Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K230976

Trade/Device Name: Arthrex Radiopaque FiberTape Cerclage sutures Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: July 24, 2023 Received: July 25, 2023

Dear Stacy Valdez:

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

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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) 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,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K230976

Device Name

Arthrex Radiopaque FiberTape cerclage sutures

Indications for Use (Describe)

Arthrex Radiopaque FiberTape sutures are 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 autograff tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

· Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
· Sternotomy indications including the "rewiring" of osteomized sternums
· Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
· Repair of long bone fractures due to trauma or reconstruction

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	07/24/2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Stacy ValdezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 72010Stacy.valdez@arthrex.com
Name of Device	Arthrex Radiopaque FiberTape Cerclage sutures
Common Name	Bone Fixation Cerclage
Product Code	JDQ (Primary), GAT
Classification Name	21 CFR 888.3010: Bone Fixation Cerclage (Primary)21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate
Regulatory Class	II
Predicate Device	K221485: Arthrex FiberTape and TigerTape Cerclage Sutures
Additional Predicate Device	K143716: DSM Biomedical DRP Cable
Reference Device(s)	K170206: Arthrex FiberTape CerclageK193575: Arthrex SutureTape
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtainclearance for the Arthrex Radiopaque FiberTape Cerclage Sutures.
Device Description	The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbablebraided sutures assembled on an ABS loader. The Radiopaque FiberTapeCerclage implant is hitched around the post of the ABS loader whichallows the nitinol wire to pass through the knot. The devices aremanufactured from a polyblend of Ultra High Molecular WeightPolyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3),and polyester materials.
Indications for Use	Arthrex Radiopaque FiberTape cerclage sutures are intended for use insoft tissue approximation and or ligation. These sutures may beincorporated, as components, into surgeries where constructs includingthose with allograft or autograft tissues are used for repair.
	When used as bone fixation cerclage the sutures are intended for:• Trochanteric reattachment after trochanteric osteotomy followingtotal hip arthroplasty)• Sternotomy indications including the “rewiring” of osteomizedsternums• Trauma surgery indications including olecranon, ankle, patella andsome shoulder fracture rewiring- Treatment of anterior glenoid bone loss using the Latarjet or boneblock procedure (allograft or autograft)• Repair of long bone fractures due to trauma or reconstruction
Performance Data	The submitted testing data, tensile strength, cyclic displacement, andcreep displacement, demonstrates that the Arthrex RadiopaqueFiberTape Cerclage sutures are substantially equivalent to the additionalpredicate device DSM Biomedical DRP Cable (K143716).
	Bacterial Endotoxins Test (BET) was performed on the ArthrexRadiopaque FiberTape Cerclage Sutures per EP 2.6.14/USP <85> to

	demonstrate that the device meets pyrogen limit specifications.
Technological Comparison	Compared to the primary predicate device Arthrex FiberTape andTigerTape Cerclage Sutures (K221485) and additional predicate deviceDSM Biomedical DPR Cable (K143716), the proposed ArthrexRadiopaque FiberTape Cerclage sutures have the same fundamentalscientific technology, design, packaging, sterility, shelf-life, and MRIsafety labeling. The proposed Arthrex Radiopaque FiberTape Cerclagesutures contain UHMWPE which incorporates Bismuth Trioxide (Bi2O3);whereas the primary predicate device Arthrex FiberTape and TigerTapeCerclage sutures (K221485) do not contain Bismuth Trioxide (Bi2O3).However, the Cerclage sutures cleared under additional predicate deviceDSM Biomedical DPR Cable (K143716) contain UHMWPE whichincorporates Bismuth Trioxide (Bi2O3).
	Any differences between the proposed devices and the predicatedevices are considered minor and do not raise new or differentquestions concerning safety or effectiveness.
Conclusion	The Arthrex Radiopaque FiberTape Cerclage sutures are substantiallyequivalent to the predicate device in which the basic design featuresand intended use are the same. Any differences between the proposeddevice and the predicate device are considered minor and do not raisequestions concerning safety and effectiveness. Based on the indicationsfor use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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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.