The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 – 5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
• Hip: Capsular Repair, acetabular labral repair.

Device Description

The Arthrex SwiveLock Anchor is a PEEK two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock device, focusing on an additional indication for meniscal root repair. It does not contain information about an AI/ML-driven medical device, but rather a mechanical medical device (a suture anchor). As such, many of the requested categories for AI/ML performance studies are not applicable.

However, I can extract the information relevant to the device's performance testing for its new indication.

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

Acceptance Criteria	Reported Device Performance
Mechanical Testing
Ultimate load for meniscal root repair within acceptable range	Ultimate load of Arthrex SwiveLock is within the acceptable range for meniscal root repair.
Cyclic displacement for meniscal root repair within acceptable range	Cyclic displacement of Arthrex SwiveLock is within the acceptable range for meniscal root repair.
Biocompatibility Testing
Device meets pyrogen limit specifications	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate the device meets pyrogen limit specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the mechanical or biocompatibility testing. The data provenance is also not specified, as this is a submission to the FDA (USA) and the tests are generally conducted internally or by contract labs.

3. 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, as this is a mechanical medical device, not an AI/ML device requiring expert ground truth for classification/detection tasks. The "ground truth" here is established by standardized testing methods and specifications.

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

Not applicable, as this is a mechanical medical device.

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, as this is a mechanical medical device, not an AI/ML device.

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

Not applicable, as this is a mechanical medical device, not an AI/ML device.

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

For the mechanical performance, the "ground truth" is defined by established engineering and biomechanical principles, and the acceptable ranges for ultimate load and cyclic displacement are likely derived from cadaveric studies, clinical literature on meniscal root repair, or comparison to predicate devices/established surgical benchmarks.

For biocompatibility, the ground truth is based on recognized consensus standards (EP 2.6.14/USP <85>) for bacterial endotoxin limits.

8. The sample size for the training set

Not applicable, as this is a mechanical medical device, not an AI/ML device requiring a training set.

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

Not applicable, as this is a mechanical medical device, not an AI/ML device.

Summary

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August 6, 2018

Arthrex Inc. David Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K173845

Trade/Device Name: Arthrex SwiveLock Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 27, 2018 Received: June 29, 2018

Dear David Rogers:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

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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Indications for Use

510(k) Number (if known) K173845

Device Name Arthrex SwiveLock

Indications for Use (Describe)

The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:

· Shoulder: · Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 -5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)

· Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

· Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

· Hip: Capsular Repair, acetabular labral 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared	June 27, 2018
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	David L RogersRegional Manager, Regulatory Affairs1-239-643-5553, ext. 71924david.rogers@arthrex.com
Name of Device	Arthrex SwiveLock
Common Name	Suture Anchor
Product Code	MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K151342: Arthrex SwiveLock Anchors
Purpose ofSubmission	This traditional 510(k) premarket notification is submitted to obtain meniscalroot repair indications for the Arthrex SwiveLock C anchor cleared under K15342.
Device Description	The Arthrex SwiveLock Anchor is a PEEK two-component, knotless suture anchorcomprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on thedriver shaft.
Indications for Use	The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) tobone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in thefollowing procedures:• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction.• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles TendonRepair, Hallux Valgus Reconstruction, Mid-foot reconstruction,Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.• Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstructionor repair (4.75 – 5.5. SwiveLock only). Meniscal root repair (4.75 PEEKSwiveLock C only)• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction, Radial Collateral LigamentReconstruction.• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar orRadial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.• Hip: Capsular Repair, acetabular labral repair.
Performance Data	Pull-out and cyclic displacement testing was conducted to demonstrate that theultimate load and displacement of the Arthrex SwiveLock is within the acceptablerange range for meniscal root repair.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	The Arthrex SwiveLock is substantially equivalent to the predicate device in whichthe basic design features and intended uses are the same. Any differences

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between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness.

Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex SwiveLock is substantially equivalent to the currently marketed predicate device.

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.