The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).

Device Description

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with an anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor, which seeks to obtain pediatric indications and an extended shelf life for an existing device. It largely focuses on mechanical testing, a review of clinical literature, and real-world data to demonstrate substantial equivalence to predicate devices, rather than an AI-powered device's performance study.

Therefore, many of the requested details regarding acceptance criteria for an AI device, specific study methodologies (like MRMC, standalone AI performance), ground truth establishment for AI training/testing, expert qualifications, and adjudication methods are not present in the provided document. The document details testing for a physical medical device (suture anchor).

However, I can extract information related to the performance data and the "study" (testing) that was done to support the submission for the physical device.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" here refer to the standards the physical device needed to meet to demonstrate substantial equivalence, particularly concerning the proposed modifications (pediatric indication, extended shelf life).

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength (Ultimate Load & Cyclic Displacement)	Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device. The results demonstrated that the modifications do not negatively impact mechanical strength.
Pyrogenicity (Bacterial Endotoxin)	Bacterial endotoxin testing per EP 2.6.14/USP <85> was conducted, demonstrating that the device meets pyrogen limit specifications.
Effectiveness in Proposed Patient Population (Pediatric)	Clinical literature review showed the device is effective when used in the proposed patient population with skeletally mature bone.
Equivalence in Outcomes for Different Age Groups (Skeletally Mature Pediatric vs. Adult)	Real World Data/Evidence from the Surgical Outcomes System registry showed no statistical differences in patient outcomes for those less than 22 years of age versus those greater than 22 years of age.

Study Details (Based on Provided Text)

1. Sample sized used for the test set and the data provenance:

Mechanical Testing: Not explicitly stated (e.g., number of anchors tested), but it was performed on the "subject device" and "predicate device." No geographical provenance is specified.
Clinical Literature: The text states "Clinical literature was provided on the subject devices involving the proposed patient population of skeletally mature pediatric patients." The number of studies or patients is not specified. It's a retrospective review of existing data.
Real World Data/Evidence: "Real World Data/Evidence is provided from the Surgical Outcomes System registry." The sample size (number of patients) is not specified, but it compares "patients less than 22 years of age versus patients greater than 22 years of age." The provenance of this registry data (e.g., country of origin) is not specified. This is retrospective data.

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

This concept is not applicable here as the "ground truth" for a physical medical device's performance primarily comes from engineering and clinical outcome data, not expert consensus on image interpretation. For the clinical literature review and RWD, the "truth" is established by the clinical outcomes themselves, as documented in studies and registries.

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

This concept applies to interpreting complex data, typically images or clinical scenarios, often for AI or diagnostic devices. It is not relevant to the mechanical/biological testing or the clinical literature/RWD review described for this physical medical device.

4. 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:

No. This study type is for evaluating reader performance with and without AI assistance for diagnostic or prognostic devices. It is not relevant for a physical medical device like a suture anchor.

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

No. This applies to AI algorithms. Not relevant for this physical medical device.

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

Mechanical Testing: Ground truth established through direct physical measurement and engineering standards (e.g., force applied, displacement measured).
Pyrogenicity Testing: Ground truth established by laboratory assay results meeting specified pyrogen limits.
Clinical Literature/Real World Data: Ground truth is clinical outcomes data (e.g., success of repair, complications, patient outcomes), as documented in published literature and registries.

7. The sample size for the training set:

Not applicable in the context of this device. This pertains to machine learning models. This submission is for a physical medical device.

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

Not applicable. This pertains to machine learning models. This submission is for a physical medical device.

Summary

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April 19, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Arthrex Inc. Kelsey Roberts Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108

Re: K203495/S001

Trade/Device Name: Arthrex SwiveLock Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: March 15, 2021 Received: March 16, 2021

Dear Kelsey Roberts:

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 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

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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.

Laura C. Rose -S

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K203495

Device Name Arthrex SwiveLock Anchor

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED,

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510(k) Summary

Date Prepared	March 10, 2021
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Kelsey N. RobertsRegulatory Affairs Associate Specialist1-239-643-5553, ext. 72257Kelsey.Roberts@arthrex.com
Name of Device	Arthrex SwiveLock Suture Anchor
Common Name	Suture Anchor
Product Code(s)	MAIMBI
Classification Name(s)	21 CFR 888.3040: Smooth or threaded metallic bone fastener21 CFR 888.3030: Single/multiple component metallic bone fixation appliances andaccessories
Regulatory Class	II
Predicate Device(s)	K191226: Arthrex SwiveLock Suture AnchorK201749: Arthrex SwiveLock Anchor
Reference Device(s)	K173240: Arthrex PushLockK173845: Arthrex SwiveLockK190728 - Arthrex SwiveLock AnchorsK192441- Arthrex SwiveLock AnchorsK143745 – Arthrex Corkscrew and SwiveLock Suture Anchors
Purpose of Submission	This premarket notification is submitted to obtain pediatric indications for theArthrex SwiveLock Suture Anchors cleared under K191226 and K201749.
Device Description	The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised ofan eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mountedon a driver with an anchor body and eyelet physically separated on the driver shaft.Arthrex 510(k) cleared suture may also be provided with the device.
Comparison Summaryof TechnologicalCharacteristics andModificationsProposed	The proposed devices have the same technological characteristics (device design,sterilization, and biocompatibility). The proposed device modification consists of theadditional patient population including pediatric patients in skeletally mature boneand an extended shelf life.
Indications for Use	The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bonein the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally maturepediatric and adult patients for the following procedures:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps TenodesisCapsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulo labral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, HalluxValgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/TendonRepair, and Bunionectomy
	Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, PosteriorOblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary oradjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFLRepair/Reconstruction(3.9 SwiveLock Only)
	Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial CollateralLigament Reconstruction
	Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral LigamentReconstruction, and Lateral Epicondylitis repair
	Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mmPEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mmPEEK SwiveLock suture anchors only).
Performance Data	Ultimate load testing and cyclic displacement was performed on the subject deviceand compared to the predicate device to demonstrate that the modifications do notnegatively impact mechanical strength.
	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.
Clinical Literature	Clinical literature was provided on the subject devices involving the proposed patientpopulation of skeletally mature pediatric patients. The reviewed literature shows thedevice is effective when used in the proposed patient population with skeletallymature bone.
Real WorldData/Evidence	Real World Data/Evidence is provided from the Surgical Outcomes System registry.Based on the patient outcomes, there are no statistical differences in patients less 22years of age versus patients greater than 22 years of age.
Conclusion	The Arthrex SwiveLock Suture Anchors are substantially equivalent to the predicatedevices in which the basic design features and intended use are the same. Anydifferences between the Arthrex proposed device and the predicate device areconsidered minor and do not result in new or different questions of safety oreffectiveness. Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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Regulation Number and Section

§ 888.3030 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.