The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

Device Description

The GraftMax™ Button, ALB (Adjustable Loop Button) with Button Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone) with Button Cradle are sterile, single use devices. The button and cradle used together measure 21mm in length and 6mm in width. The devices are oval shaped and manufactured of titanium alloy. The devices are designed with five (5) holes that sutures can be threaded through.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the GraftMax™ Button, ALB with Cradle and GraftMax™ Button, BTB with Cradle. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory approval.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" alongside specific numerical "reported device performance" values for parameters like ultimate fixation strength or cyclic testing. Instead, it lists the types of performance data collected to support substantial equivalence. The implication is that the performance of the new device was compared against existing standards or the predicate device's performance, and found to be acceptable. Without specific numerical criteria or results, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed.

However, based on the provided text, the types of tests performed indicate the areas where performance was evaluated.

Acceptance Criteria Category	Reported Device Performance (as implied by completion of testing)
Reliability	Testing completed, implies device reliability met expectations.
Packaging	Testing completed, implies packaging integrity met expectations.
Ultimate Fixation Strength	Testing completed, implies fixation strength met expectations.
Cyclic	Testing completed, implies durability/fatigue resistance met expectations.
Sterilization	Testing completed, implies sterilization efficacy met expectations.
Verification Testing	Testing completed, implies device functionality met expectations.
Transportation	Testing completed, implies device integrity during transport met expectations.
Biocompatibility	Testing completed, implies materials are biocompatible.
User Validation	Testing completed, implies usability/user-friendliness met expectations.
Shelf-life	Testing completed, implies shelf-life met expectations.

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

The document does not specify the sample sizes used for any of the performance tests (Reliability, Packaging, Ultimate Fixation Strength, Cyclic, Sterilization, Verification Testing, Transportation, Biocompatibility, User Validation, Shelf-life).

The data provenance is also not explicitly stated. It can be inferred that the testing was conducted by or for CONMED Corporation in support of their 510(k) submission to the FDA, but details like country of origin of the data or whether it was retrospective or prospective are not provided. Given the nature of a 510(k) submission for a physical device, these would typically be laboratory or in-vitro tests, likely prospective experiments designed to evaluate the new device.

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

This information is not applicable and therefore not provided in the document. The device is a physical fastener for surgical use, not an AI/software device that requires ground truth established by experts for classification or diagnosis. The "ground truth" for this device's performance would be objective measurements obtained through engineering and material science testing.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies involving expert review or interpretation, which is not the case for the performance testing of this mechanical 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

This information is not applicable and therefore not provided. An MRMC study is relevant for diagnostic or interpretive AI systems. The GraftMax™ Button is a physical surgical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided. "Standalone" performance testing for an algorithm is irrelevant to a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a physical device like the GraftMax™ Button, the "ground truth" for performance evaluations typically comes from objective, quantitative measurements obtained through standardized engineering and material science testing. For example:

Ultimate Fixation Strength: Measured numerically (e.g., in Newtons) under specified load conditions.
Cyclic Testing: Number of cycles to failure under defined load parameters.
Biocompatibility: Results from cell culture or in-vivo animal tests adhering to ISO standards.
Sterilization: Microbiological testing to confirm sterility assurance levels.

The document implicitly refers to these types of objective data as the basis for performance evaluation.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The concept of a "training set" pertains to machine learning algorithms. This document describes a physical medical device that does not involve artificial intelligence or machine learning.

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

This information is not applicable and therefore not provided, as there is no training set for a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 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

July 9, 2015

CONMED Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 525 French Road Utica, New York 11502

Re: K151037

Trade/Device Name: GraftMax™ Button, ALB with Cradle and GraftMax™ Button, BTB with Cradle Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: June 5, 2015 Received: June 10, 2015

Dear Ms. Freeman:

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 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

{1}------------------------------------------------

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/Resourcesfor You/Industry/default.htm. 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/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 yours,

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151037

Device Name

GraftMax™ Button, ALB with Cradle GraftMax™ Button, BTB with Cradle

Indications for Use (Describe)

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."

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape on the left. To the right of the square is the word "Conmed" in black, with the word "Corporation" in smaller blue letters underneath. The logo is simple and modern, and the colors are clean and professional.

510(k) SUMMARY

I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York Phone: 727-399-5416 Fax: 727-399-5264 Date Prepared: June 26, 2015

Company Contact

Nyrobia Freeman Regulatory Affairs Specialist Telephone (727) 399-5416 Fax (727) 399-5264

II. DEVICE

Trade of Device:	GraftMax™ Button, ALB (Adjustable Loop Button) withCradle and GraftMax™ Button, BTB (Bone-Tendon-Bone)with Cradle
Common Name:	Titanium Fixation Device
Classification Name:	Fastener, Fixation, Non-degradable, Soft-Tissue
Regulatory Class:	Class II
Product Codes:	MBI
Regulation:	21 CFR Part 888. 3040

III. PREDICATE DEVICE

Device Name:	GraftMax™ Button, ALB (Adjustable Loop Button) andGraftMax™ Button, BTB (Bone-Tendon-Bone)
Company Name:	CONMED Corporation
510(k) #:	K070780

IV. DEVICE DESCRIPTION

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, with a blue line underneath. Below the line is the word "CORPORATION" in smaller, black letters.

V. INDICATIONS FOR USE

The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are identical in intended use and principles of operation to the predicate device with exceptions of dimensions, sterilization and packaging.

	Proposed Device	Predicate Device
Dimensions	21mm x 6mm	14mm x 4.5mm
Sterilization	Implant- GammaCradle- EtO	Implant - Gamma

Packaging	Implant - Sterile, single usepackageCradle – Sterile, single usepackage , packagedseparately	Implant- Sterile, single usepackage

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Completed testing includes the following:

Reliability ●
Packaging ●
Ultimate Fixation Strength ●
Cyclic ●
Sterilization
Verification Testing ●
. Transportation
Biocompatibility ●
User Validation ●
Shelf-life

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square on the left side with a white, curved shape inside. To the right of the square is the word "Conmed" in black, sans-serif font. Below the word "Conmed" is the word "Corporation" in a smaller, sans-serif font, also in black.

VIII. CONCLUSION

The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are substantially equivalent in design, manufacturing materials, intended use, principles of operation to the predicate GraftMax™ Button ALB, and GraftMax™ Button, BTB and raises no new issues of safety or effectiveness.

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.