The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis 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, Metatarsal Ligament Repair, Hallux Valgus Repair/Tendon Reconstruction, Mid-foot Reconstruction, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
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: Acetabular Labral Repair.

Device Description

The Arthrex PushLock Anchors family is similar to the predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Arthrex PushLock Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence in materials and overall design to predicate devices.	The Arthrex PushLock Anchors family is similar to the predicate devices in materials and overall design. The proposed devices are composed of Bio, BioComposite, and Peek materials that are substantially equivalent to the predicate devices.
Biomechanical and mechanical testing (insertion and pull-out strength) demonstrates substantial equivalence to predicate devices.	The submitted mechanical testing data demonstrated that the biomechanical and mechanical testing (insertion and pull-out strength) of the proposed devices is substantially equivalent to the biomechanical and mechanical testing of the predicate devices.
Substantial equivalence to currently marketed predicate devices based on indication for use, technological characteristics, and comparison.	Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the PushLock Anchors family is substantially equivalent to currently marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify sample sizes for a 'test set' in the traditional sense of a clinical trial or AI model validation. The study described is focused on demonstrating substantial equivalence through mechanical and biomechanical testing. Therefore, the "test set" here refers to the samples of Arthrex PushLock Anchors and predicate devices used in the mechanical and biomechanical testing.

Sample Size: Not explicitly stated for specific tests, but implies multiple samples were tested for each device type (proposed and predicate) to generate the "mechanical testing data."
Data Provenance: Not explicitly stated, but as this is a 510(k) submission from a US manufacturer (Arthrex, Inc. in Naples, FL), it can be inferred that the testing was conducted either internally by the manufacturer or by a contracted laboratory, likely within the US. The nature of the testing (mechanical/biomechanical) would make it similar to a prospective study aimed at generating specific data points for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this submission. The "ground truth" for this type of device (suture anchor) in a 510(k) submission is established through:

Engineering specifications and material science: For material equivalence.
Mechanical and biomechanical testing standards: For performance equivalence (e.g., pull-out strength, insertion strength).
Comparison to legally marketed predicate devices: For intended use and technological characteristics.

There's no mention of human experts interpreting data to establish a 'ground truth' in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or imaging-based AI assessments where multiple human readers interpret data that is inherently subjective or requires expert consensus. The assessment here is based on objective mechanical measurements and comparison to established predicate properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in tasks like image interpretation. The Arthrex PushLock Anchors are a physical medical device (suture anchors), not a diagnostic tool or an AI algorithm, so an MRMC study would be irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an algorithm. The "standalone" performance here would refer to the device's inherent mechanical properties, which are evaluated through the biomechanical and mechanical testing.

7. Type of Ground Truth Used

The ground truth used here is primarily:

Predicate Device Data: The mechanical and material properties of the legally marketed predicate devices (Arthrex Bio-Composite Suture Tak Anchors, Arthrex BioComposite Suture Anchors, Arthrex PushLock, Tak and Corkscrew Suture Anchors) served as the benchmark or "ground truth" for comparison.
Biomechanical and Mechanical Measurement Data: Objective, quantifiable results from laboratory testing regarding insertion and pull-out strength.
Material Composition Standards: Specifications for the Bio, BioComposite, and Peek materials.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission pertains to a physical medical device. The "design iterations" and "testing" involved in its development might be analogous to a training phase, but there isn't a quantifiable "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the AI context. The development process would have involved engineering design principles, material science, and iterative testing where the "ground truth" for design decisions was based on desired mechanical performance, biocompatibility, and manufacturing feasibility, guided by existing knowledge of successful predicate devices.

Summary

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510(k) Summary of Safety and Effectiveness Date Summary Prepared June 11, 2010 OCT 22 2010 Manufacturer/Distributor Arthrex, Inc. /Sponsor 1370 Creekside Boulevard Naples, FL 34108-1945 USA Courtney Smith 510(k) Contact Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext. 1720 Fax: 239/598.5508 Email: Courtney.smith@arthrex.com Arthrex PushLock Anchors Trade Name Common Name Suture Anchor Product Code -MAI - Fastener, Fixation, Biodegradable, Soft Tissue Classification Name HWC - Screw, Fixation, Bone Predicate Devices K091844: Arthrex Bio-Composite Suture Tak Anchors K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors Device Description and The Arthrex PushLock Anchors family is similar to the Intended Use predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip. Please see indications for use form for specific indications. Substantial Equivalence The Arthrex PushLock Anchors are substantially equivalent to the Arthrex BioComposite Suture Anchors and the Arthrex Summary PushLock, Tak and Corkscrew Suture Anchors predicates, in which the basic features and intended uses are the same. Any differences between the PushLock Anchors and the predicates are considered minor and do not raise questions concerning safety and effectiveness. The proposed devices are composed of Bio. BioComposite and Peek materials that are substantially equivalent to the predicate devices. The submitted mechanical testing data demonstrated that the

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biomechanical and mechanical testing (insertion and pull-outstrength) of the proposed devices is substantially equivalent to thebiomechanical and mechanical testing of the predicate devices.
Based on the indication for use, technological characteristics, andthe comparison to the predicate devices, Arthrex, Inc. hasdetermined that the PushLock Anchors family is substantiallyequivalent to currently marketed predicate devices.

and the comments of the comments of the comments of the comments of

and the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

OCT 2 2 2010

Re: K101679

Trade/Device Name: Arthrex PushLock™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: October 19, 2010 Received: October 24, 2010

Dear Ms. Smith:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Courtney Smith

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Harbau Brehm

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101679: Arthrex PushLock Anchors, Additional Information, October 19, 2010

Appendix 4

Indications for Use

510(k) Number: K101679

Arthrex PushLock™ Device Name:

The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis 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 Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Foot/Ankle: Repair, Repair/Tendon Hallux Valgus Reconstruction, Mid-foot Reconstruction, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis 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: Acetabular Labral Repair.

Prescription Use __ X_AND/OR Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(21 CFR 801 Subpart C)

PAGE 1 of 1

Jonutu fer mxn
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101679

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.