Arthrex FiberTape and TigerTape 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
· To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

Device Description

The proposed Arthrex FiberTape and TigerTape Cerclage Sutures are available as flat braided sutures assembled in a loop configuration. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, and nylon materials. These materials are identical to those cleared in K221485 and K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader. The proposed Arthrex FiberTape and TigerTape Cerclage Sutures may be used with or without the cleared Arthrex Dog Bone Button (K220947).

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for a medical device (Arthrex FiberTape and TigerTape Cerclage Sutures). It is a regulatory submission to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, most of the requested information regarding acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of document because the submission focuses on mechanical and biological equivalency for a physical suture device.

However, I can extract information related to the performance data and the comparison made for substantial equivalence:

Information Extracted from the Document:

Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures
Predicate Device: K220947 Arthrex Knotless AC Repair Devices
Reference Devices: K221485 Arthrex FiberTape and TigerTape Cerclage Sutures, K170206 Arthrex FiberTape Cerclage
Purpose of Submission: To obtain an additional indication: "To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption."

Given that this document is for a physical medical device (sutures) and a 510(k) submission, the traditional "acceptance criteria" and "study" framework for AI/software-based medical devices (which would involve test sets, expert ground truth, MRMC studies, etc.) does not apply directly.

Instead, the "study" proving the device meets the criteria of substantial equivalence involves performance testing to demonstrate that the new device is as safe and effective as the predicate device.

Here's how to frame the information from the document in relation to your request, highlighting what is and isn't present:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (for substantial equivalence): The new device must demonstrate similar mechanical properties and biocompatibility to the predicate device, especially for the new indication. The implied acceptance criteria are that the new device's performance in specified mechanical tests is comparable to or better than the predicate.
Reported Device Performance:

Performance Metric	Reported Device Performance (Arthrex FiberTape and TigerTape Cerclage Sutures)	Acceptance Criteria / Comparison to Predicate (Arthrex Knotless AC Repair Devices K220947)
Ultimate Load	Data was submitted	Demonstrates substantial equivalence to predicate.
Cyclic Displacement	Data was submitted	Demonstrates substantial equivalence to predicate.
Bacterial Endotoxin	Conducted per EP 2.6.14/USP <85>	Meets pyrogen limit specifications.
Materials	Polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, nylon	Identical to those cleared in K221485 and K170206 (reference devices).
Fundamental Scientific Technology	N/A (identical to reference devices)	Identical to predicate/reference devices.
Packaging, Sterility, Shelf-life, MRI Safety Labeling	N/A (identical to reference devices)	Identical to predicate/reference devices.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for the mechanical tests (ultimate load, cyclic displacement, bacterial endotoxin). This information would typically be found in the full testing report, which is not part of this summary.
Data Provenance: Not specified in terms of country of origin. The tests were likely conducted internally by Arthrex Inc. or by a contract lab. These are performance tests on the device materials/constructs, not clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device with objective mechanical and biological testing. There is no human "ground truth" to establish for these tests (e.g., no interpretation of images or clinical outcomes by experts to be used as ground truth).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As above, this is objective mechanical and biological testing, not interpretation requiring adjudication.

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:

Not Applicable. This is for a physical surgical suture, not an AI/software device used by human readers for diagnosis or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Mechanical and Biological Properties: The "ground truth" for demonstrating substantial equivalence relies on standard, recognized testing methodologies for medical devices (ISO, ASTM standards, or equivalent) for properties like tensile strength, fatigue, and biocompatibility (e.g., endotoxin limits). There is no "expert consensus" or "pathology" in the typical sense for these types of tests.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/machine learning device.

In summary, this document is a regulatory submission for a physical medical device (suture) seeking expanded indications based on demonstrated substantial equivalence through objective mechanical and biological performance testing, rather than a study for an AI/software device that would involve the complex aspects of expert-annotated test and training datasets.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 6, 2023

Arthrex Inc. Ruth Segall Regulatory Affairs Specialist I 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K232755

Trade/Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: HTN, HWC, JDQ, GAT Dated: September 7, 2023 Received: September 8, 2023

Dear Ruth Segall:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and

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21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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,

Christopher Ferreira -S

for

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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)

K232755

Device Name Arthrex FiberTape and TigerTape Cerclage Sutures

Indications for Use (Describe)

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
· To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

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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K232755 Page 1 of 4

510(k) Summary

Date Prepared	October 6, 2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ruth SegallRegulatory Affairs Specialist I1-239-598-4302, ext. 71764Ruth.Segall@arthrex.com
Trade Name	Arthrex FiberTape and TigerTape Cerclage Sutures
Common Name	Bone Fixation Cerclage, Suture and Washer
Product Code	HTN - Primary Product CodeHWCJDQGAT
Classification Name	21 CFR 888.3030: Single/multiple component metallicbone fixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener21 CFR 888.3010: Bone Fixation Cerclage21 CFR 878.5000: Nonabsorbable Poly(ethylene)Terephthalate Surgical Suture
Regulatory Class	II
Primary Predicate Device	K220947 Arthrex Knotless AC Repair Devices
Reference Devices	K221485 Arthrex FiberTape and TigerTape CerclageSuturesK170206 Arthrex FiberTape Cerclage
Purpose of Submission	This special 510(k) premarket notification is submittedto obtain the additional indication to provide fixationduring the healing process following syndesmotictrauma, such as fixation of acromioclavicular separationdue to coracoclavicular ligament disruption for theArthrex FiberTape and TigerTape Cerclage Sutures.
Device Description	The proposed Arthrex FiberTape and TigerTapeCerclage Sutures are available as flat braided suturesassembled in a loop configuration. The devices aremanufactured from a polyblend of Ultra High Molecular
	Weight Polyethylene (UHMWPE), polyester, and nylonmaterials. These materials are identical to those clearedin K221485 and K170206. For the loop assembly, thelooped end of the suture is tied as a hitch over a sheaththat secures a double loop or tied over the post of anABS loader. The proposed Arthrex FiberTape andTigerTape Cerclage Sutures may be used with orwithout the cleared Arthrex Dog Bone Button(K220947).
Indications for Use	Arthrex FiberTape and TigerTape Cerclage Sutures areintended for use in soft tissue approximation and orligation. These sutures may be incorporated, ascomponents, into surgeries where constructs includingthose with allograft or autograft tissues are used forrepair.
	When used as bone fixation cerclage the sutures areintended for:• Trochanteric reattachment after trochantericosteotomy following total hip arthroplasty• Sternotomy indications including the "rewiring" ofosteomized sternums• Trauma surgery indications including olecranon,ankle, patella and some shoulderfracture rewiring• Treatment of anterior glenoid bone loss using theLatarjet or bone block procedure (allograft orautograft).• Repair of long bone fractures due to trauma orreconstruction• To provide fixation during the healing processfollowing syndesmotic trauma, such as fixation ofacromioclavicular separation due to coracoclavicularligament disruption.
Performance Data	The submitted testing data, ultimate load and cyclicdisplacement, demonstrates that the Arthrex FiberTapeand TigerTape Cerclage Sutures are substantiallyequivalent to the predicate device Arthrex Knotless AC
	Repair Devices (K220947). Bacterial endotoxin per EP2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Technological Comparison	Compared to the predicate device Arthrex Knotless ACRepair Devices (K220947) and reference devices ArthrexFiberTape and TigerTape Cerclage Sutures (K221485)and Arthrex FiberTape Cerclage (K170206), theproposed Arthrex FiberTape and TigerTape CerclageSutures have identical materials, fundamental scientifictechnology, packaging, sterility, shelf-life, and MRIsafety labeling.
	The proposed device is an all-suture cerclage constructthat may be used with up to one button for the surgicaltechnique; whereas the predicate device is a sutureconstruct used with two metal buttons (either pre-assembled or attached).
	Based on the intended use, fundamental scientifictechnology, and the data provided in this Special 510(k),Arthrex has determined that the proposed ArthrexFiberTape and TigerTape Cerclage Sutures aresubstantially equivalent to the predicate device ArthrexKnotless AC Repair Devices, K220947 and referencedevices, Arthrex FiberTape and TigerTape CerclageSutures, K221485 and Arthrex FiberTape Cerclage,K170206. Any differences between the proposed deviceand predicate device are considered minor and do notraise different questions concerning safety andeffectiveness.
Conclusion	The Arthrex FiberTape and TigerTape Cerclage Suturesare substantially equivalent to the predicate device inwhich the basic design features and intended use areidentical. Any differences between the Arthrexproposed device and the predicate device areconsidered minor and do not raised questionsconcerning safety and effectiveness. Based on theindications for use, technological characteristics, andthe summary of data submitted, Arthrex Inc. has

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determined that the proposed device is substantially
equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.