The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, 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 and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or 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 two-component, knotless suture anchor composed 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. Arthrex suture may also be provided with the device.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Arthrex SwiveLock Anchors. It focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, comprehensive clinical trial for a novel AI device. Therefore, the questions related to AI-specific study design (such as human reader improvement with AI assistance, ground truth for training sets, etc.) are not directly applicable to this document's content.

However, I can extract the information relevant to the device's performance testing and how it meets acceptance criteria for substantial equivalence to its predicate.

Here's the relevant information based on the provided text, framed as closely as possible to your request for acceptance criteria and study details:

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

For a 510(k) submission for a modification, the "acceptance criteria" are typically defined by demonstrating that the modified device performs equivalently to the predicate device in relevant performance tests, or that the modifications do not introduce new safety or effectiveness concerns. The "reported device performance" is then the outcome of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: The modified device must perform equivalently to the predicate device in terms of:
* Pull-out strength	Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate.
* Compressive load resistance	Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate.
* Mode of failure	Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate.
Biocompatibility/Safety: The device meets pyrogen limits.	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications.
Overall Substantial Equivalence: Differences between the proposed device and predicate are minor and do not raise questions concerning safety or effectiveness.	The Arthrex SwiveLock Anchors are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety or effectiveness.

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

Sample Size: The document does not specify the exact number of units or samples used for the pull-out, compressive load, and mode of failure testing, nor for the bacterial endotoxin testing. This level of detail is typically found in the full test reports, which are not part of this summary.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a manufacturing modification, the testing would generally be prospective laboratory testing conducted by the manufacturer (Arthrex Inc., located in Naples, Florida, USA).

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

Not applicable. This is not a study involving human interpretation of medical images or data requiring expert consensus for ground truth. The "ground truth" for mechanical testing is established by the physical testing equipment and methods themselves (e.g., measuring force, observing failure points).

4. Adjudication method for the test set

Not applicable. This is not a study involving human-based data interpretation or classification where adjudication would be necessary.

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 not an AI device or a study involving human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the mechanical tests (pull-out, compressive load, mode of failure), the ground truth is established through physical measurement and observation during standardized laboratory testing. For the bacterial endotoxin test, the ground truth is established by laboratory assay results against a pyrogen limit specification.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set. The device is a modification of an existing mechanical anchor.

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

Not applicable. As above, there is no AI training set.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 4, 2017

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

Re: K171141

Trade/Device Name: Arthrex SwiveLock Anchors 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: April 14, 2017 Received: April 18, 2017

Dear Mr. 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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K171141

Device Name Arthrex SwiveLock Anchors

Indications for Use (Describe)

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

Shoulder: Rotator Cuff Repair, 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 and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary: K171141

Date Prepared	April 14, 2017
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	David L RogersProject Manager, Regulatory Affairs1-239-643-5553, ext. 71924david.rogers@arthrex.com
Name of Device	Arthrex SwiveLock Anchors
Common Name	Suture Anchor
Product Code	MAI, MBI
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K151342: Arthrex SwiveLock Anchors
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for themodification to the eyelet of the Arthrex SwiveLock Suture Anchors cleared underK151342.
Device Description	The Arthrex SwiveLock Anchor is a two-component, knotless suture anchorcomposed 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. Arthrex suture may also be provided with the device.
Indications for Use	The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) tobone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing procedures:Shoulder: Rotator Cuff Repair, 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 and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, andIlliotibial Band Tenodesis. Secondary fixation of ACL/PCL reconstructionor repair (4.75 - 5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction.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, compressive load, and insertion mode of failure testing was performedto demonstrate that the SwiveLock Anchors with the proposed modified eyeletare substantially equivalent to the predicate.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.

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Conclusion	The Arthrex SwiveLock Anchors are substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.
	Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially 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.