Indications for Use: The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Description

The 2.8 mm/3.3 mm PopLok™ Suture Anchors are sterile, single use devices. The 2.8 mm/3.3 mm PopLokTM Suture Anchors are manufactured from PEEK Optima LT1 (polyetheretherketone) material. The anchors are available in two (2) sizes (2.8 mm and 3.3 mm diameters). The anchors are supplied with one (1) #2 Hi-Fi® suture or two (2) #0 Hi-Fi® sutures, packaged separately. The anchors are provided sterile, single use and preloaded on a disposable driver with a threader.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the 2.8 mm/3.3 mm PopLok Suture Anchors. This documentation focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or diagnostic device would.

Therefore, many of the requested elements for a detailed study of diagnostic or AI-assisted devices (like sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, training set details, etc.) are not applicable or available from this type of regulatory document.

However, I can extract information related to the performance testing conducted to support substantial equivalence.

Here's the information based on the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test or detailed quantitative performance results in a table format. It lists the types of verification and validation testing performed and states that the device "met the endotoxin limits" and "perform as intended." The purpose of these tests in a 510(k) submission is to demonstrate that the new device performs comparably to or better than predicate devices and does not raise new questions of safety or effectiveness.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Reliability	Consistent and expected function	Performed "as intended"
Ultimate Fixation Strength	Comparable to or better than predicate device	Performed "as intended" and "substantially equivalent"
Cyclic	Withstands repetitive loading without failure, comparable to predicate device	Performed "as intended" and "substantially equivalent"
Sterilization	Achieves sterility assurance level (SAL)	Testing conducted
Pyrogen (Bacterial Endotoxin Testing)	Meets endotoxin limits	"Met the endotoxin limits"
Biocompatibility	Material does not cause adverse biological responses	Testing conducted
Shelf-life	Maintains integrity and functionality over stated shelf life	Testing conducted
User Validation	Acceptable and safe for intended user operation	Testing conducted
Packaging	Protects device and maintains sterility	Testing conducted
Transportation	Withstands shipping conditions without damage or compromise	Testing conducted

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

Sample Size for Test Set: Not specified in the document. The tests performed ("Ultimate Fixation Strength", "Cyclic", etc.) typically involve a number of samples to achieve statistical significance but the exact count is not disclosed here.
Data Provenance: Not specified. These are laboratory/bench tests, not clinical studies. The data would be generated in a controlled testing environment, likely at the manufacturer's facilities or a contracted testing lab.

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

Not Applicable. This document describes performance testing for a physical medical device (suture anchors), not a diagnostic or AI algorithm relying on expert interpretation of data or images. Ground truth as typically defined in diagnostic studies (e.g., expert consensus on medical images or pathology results) is not relevant for this type of device submission.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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 a physical medical device (suture anchors), not an AI-assisted diagnostic or imaging device.

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

Not Applicable. For mechanical performance tests, the "ground truth" would be the objective measurements of physical properties (e.g., force, displacement, material composition) against engineering specifications, rather than expert consensus or pathology.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not Applicable. See point 8.

Summary

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December 21, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ConMed Corporation Diana Nader-Martone Regulatory Affairs Specialist 525 French Road Utica. New York 13502

Re: K181120

Trade/Device Name: 2.8 mm/3.3 mm PopLok Suture Anchors™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 21, 2018 Received: November 23, 2018

Dear Ms. Nader-Martone:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Shumaya Ali -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181120

Device Name

2.8 mm/3.3 mm PopLokTM Suture Anchors

Indications for Use (Describe)

Intended Use

The PopLok™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

Indications for Use

The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilization, throughout the healing period.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue and white graphic on the left, followed by the word "CONMED" in black, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, black letters.

510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K181120

I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: 727-399-5425 Fax: 727-399-5264

Contact Person: Diana L. Nader-Martone Date Prepared: April 26, 2018

II. DEVICE NAME

Device Name:	2.8 mm/3.3 mm PopLok™ Suture Anchors
Common Name:	Nonabsorbable Suture Anchor System
Classification Name:	Fastener, fixation, nondegradable, soft tissue
Regulatory Class:	Class II, per 21 CFR Part 888. 3040
Product Codes:	MBI

III. PREDICATE/ LEGALLY MARKET DEVICE

Device Name:	ConMed Linvatec Soft Tissue to Bone System
Company Name:	ConMed Linvatec
510(k) #:	K091549

IV. DEVICE DESCRIPTION

INTENDED USE/ INDICATIONS FOR USE V.

The PopLok™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, curved shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.

The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The following table represents a summary of the technological characteristics between the proposed and the predicate device.

	2.8 mm/3.3 mm PopLok™ Suture AnchorsProposed	ConMed Linvatec Soft Tissue to Bone System(including PopLok™ Suture Anchors)Predicate
DeviceDescription	The 2.8 mm/3.3 mm PopLok™ Suture Anchorsare sterile, single use devices. The PopLok™Suture Anchors are manufactured from PEEKOptima LT1 (polyetheretherketone) material. Theanchors are provided sterile, single use andpreloaded on a disposable driver. The anchorsare available in two (2) sizes and four (4)configurations.	The PopLok™ Suture Anchors are sterile, singleuse devices. The PopLok™ Suture Anchors aremanufactured from PEEK Optima LT1(polyetheretherketone) material. The anchors areprovided sterile, single use and preloaded on adisposable driver. The anchors are available intwo (2) sizes and four (4) configurations.
Intended Use	The PopLok™ Suture Anchor is intended toreattach soft tissue to bone in orthopedic surgicalprocedures.	The PopLok™ Suture Anchor is intended toreattach soft tissue to bone in orthopedic surgicalprocedures.
Indication for Use	The system may be used in either arthroscopic oropen surgical procedures. After the suture isanchored to the bone, it may be used to reattachsoft tissue, such as ligaments, tendons, or jointcapsules to the bone. The suture anchor systemthereby stabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization, throughout the healing period.	The system may be used in either arthroscopic oropen surgical procedures. After the suture isanchored to the bone, it may be used to reattachsoft tissue, such as ligaments, tendons, or jointcapsules to the bone. The suture anchor systemthereby stabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization, throughout the healing period.
Contraindications	1. Pathological conditions of bone which wouldadversely affect the PopLok Knotless SutureAnchor.2. Pathological conditions in the soft tissue to berepaired or reconstructed which would adverselyaffect suture fixation.3. Physical conditions that would eliminate, ortend to eliminate, adequate implant support orretard healing.4. Conditions which tend to limit the patient'sability or willingness to restrict activities orfollow directions during the healing period.5. Attachment of artificial ligaments or otherimplants.6. Foreign body sensitivity, known or suspectedallergies to implant and/or instrument materials.7. Do not use any other suture except forConMed Linvatec #2 and #0 HI-FI.8. This device is not approved for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine.	1. Pathological conditions of bone which wouldadversely affect the PopLok Knotless SutureAnchor.2. Pathological conditions in the soft tissue to berepaired or reconstructed which would adverselyaffect suture fixation.3. Physical conditions that would eliminate, ortend to eliminate, adequate implant support orretard healing.4. Conditions which tend to limit the patient'sability or willingness to restrict activities orfollow directions during the healing period.5. Attachment of artificial ligaments or otherimplants.6. Foreign body sensitivity, known or suspectedallergies to implant and/or instrument materials.7. Do not use any other suture except forConMed Linvatec #2 HI-FI.8. This device is not approved for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine.

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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" inside on the left. To the right of the square, the word "CONMED" is written in a bold, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font, with a thin blue line above it.

	2.8 mm/3.3 mm PopLok™ Suture AnchorsProposed	ConMed Linvatec Soft Tissue to Bone System(including PopLok™ Suture Anchors)Predicate
Components	PEEK anchorDisposable DriverSuture	PEEK anchorDisposable DriverSuture
TechnologicalCharacteristics	2.8 or 3.3 mm non-absorbable, PEEK anchorDisposable driverThreaderSupplied with one (1) #2 suture or two (#0) sutures packaged separately.	3.5 or 4.5 mm non-absorbable, PEEK anchorDisposable driverThreaderSupplied with one (1) #2 suture packaged separately or without suture.

PERFORMANCE DATA

Testing has been completed to demonstrate that the 2.8 mm PopLok™ Suture Anchors perform as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.

Completed testing includes the following:

Verification Testing

Reliability ●
Ultimate Fixation Strength ●
Cyclic ●
Sterilization ●
Pyrogen ●
Biocompatibility
Shelf-life ●

VIII. CONCLUSION

The 2.8 mm/3.3 mm PopLok™ Suture Anchor PopLok™ Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Soft Tissue to Bone System. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the 2.8 mm/3.3 mm PopLok™ Suture Anchor is substantially equivalent to the ConMed Linvatec Soft Tissue to Bone System (K091549).

Validation Testing

User Validation ●
Packaging ●
Transportation ●

Regulation Number and Section

N/A

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K181120

Indications for Use (Describe)

Intended Use

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) SUMMARY

I. SUBMITTER

II. DEVICE NAME

III. PREDICATE/ LEGALLY MARKET DEVICE

IV. DEVICE DESCRIPTION

INTENDED USE/ INDICATIONS FOR USE V.

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

PERFORMANCE DATA

VIII. CONCLUSION

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