The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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 CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device, specifically a suture anchor, and not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design for AI/ML devices, ground truth establishment, and expert involvement is not applicable.

The document discusses the substantial equivalence of the "CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver" to a legally marketed predicate device. The performance data section outlines the types of engineering and biological tests conducted to demonstrate the device's reliability, strength, and safety, not the performance of an AI algorithm.

To directly answer your prompt based on the provided text, but with the understanding that this is not an AI/ML device:

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

The document describes the types of tests performed but does not provide specific numerical acceptance criteria or reported performance values for each test. It states that testing was completed to demonstrate the device "performs as intended and is substantially equivalent to the predicate device."

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Reliability	Device consistently operates as designed.	Testing completed to show performance as intended.
Ultimate Fixation Strength	Sufficient strength to reattach soft tissue to bone.	Testing completed to show performance as intended.
Cyclic	Withstands repeated stress cycles without failure.	Testing completed to show performance as intended.
Sterilization	Achieves and maintains sterility.	Testing completed to show performance as intended.
Pyrogenicity	Meets endotoxin limits (non-pyrogenic).	Bacterial endotoxin testing met endotoxin limits.
Biocompatibility	Biologically compatible without adverse reactions.	Testing completed to show performance as intended.
Shelf-life	Maintains functionality and safety over its intended shelf life.	Testing completed to show performance as intended.
User Validation	Device is usable and effective by intended users.	Testing completed to show performance as intended.
Packaging	Maintains device integrity during storage and transport.	Testing completed to show performance as intended.
Transportation	Withstands transportation stresses.	Testing completed to show performance as intended.

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

Sample Size: Not specified for any of the individual tests. The document only mentions "Completed testing includes the following" list.
Data Provenance: Not specified. It's implied this is internal company testing, but no details on country of origin or retrospective/prospective nature of data are provided (as these are not relevant for a hardware/biomaterial device).

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

Not Applicable. This is a hardware medical device (suture anchor), not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Ground truth for this device would be established through engineering and biological test standards and measurements (e.g., tensile strength, material composition analysis, sterility testing results).

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing expert consensus on medical image interpretations or diagnoses, which is not relevant for the testing of a suture anchor.

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:

No. This is not an AI/ML device. MRMC studies are not applicable.

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

No. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this type of device is established through:
- Engineering test standards and specifications: e.g., defined strength requirements, material properties.
- Biological/Chemical test standards: e.g., endotoxin limits, biocompatibility standards.
- Functional performance assessments: e.g., how the device behaves during simulated use (reliability, cyclic loading).

8. The sample size for the training set:

Not Applicable. This is a hardware medical device and does not have a "training set" in the context of AI/ML.

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

Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The device's performance is validated against established scientific and engineering principles, and industry standards for medical devices.

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a symbol resembling a caduceus or staff with a serpent intertwined.

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

March 17, 2017

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

Re: K170501

Trade/Device Name: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: February 17, 2017 Received: February 21, 2017

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 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

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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 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,

Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved:	OMB No. 0910-0120
Expiration Date:	January 31, 2017
	See PRA Statement below.
510(k) Number (if known)	K170501
Device Name	CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
Indications for Use (Describe)	The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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.
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:

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Office of Chief Information Officer

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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 FDA 3881 (8/14)
Page 1 of 1

PSC Publishing Services (301) 443-6740
EF

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Image /page/3/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined with a blue line.

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

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: February 17, 2017

II. DEVICE NAME

Device Name:	CrossFT™ Knotless Biocomposite Suture Anchor withDisposable Driver
Common Name:	Bioabsorbable Suture Anchor
Classification Name:	Fastener, fixation, biodegradable, soft tissue
Regulatory Class:	Class II, per 21 CFR Part 888. 3030
Product Codes:	MAI

III. PREDICATE/ LEGALLY MARKET DEVICE

Device Name:	ConMed Linvtec CrossFT™ BC Suture Anchor
Company Name:	ConMed Linvatec
510(k) #:	K101100

IV. DEVICE DESCRIPTION

V. INTENDED USE/ INDICATIONS FOR USE

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver 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 stylized blue "C" shape on the left side. To the right of the "C" is the word "CONMED" in a bold, sans-serif font, with a blue line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.

The device 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.

	CrossFTTM Knotless Biocomposite SutureAnchor with Disposable DriverProposed	ConMed Linvatec CrossFTTM-BC Suture Anchor(also known as: GENESYSTM CrossFTTM SutureAnchor)Predicate
DeviceDescription	The CrossFTTM Knotless Biocomposite SutureAnchor with Disposable Drivers are sterile, singleuse devices. The CrossFTTM KnotlessBiocomposite Suture Anchor with DisposableDrivers is manufactured from polylactidecopolymer (96L/4D PLA) and β-TricalciumPhosphate (β-TCP). The anchors are providedsterile, single use and preloaded on a disposabledriver. The anchors are available in three sizesand nine configurations.	The ConMed Linvatec CrossFTTM-BC SutureAnchor is a device that is used to assist thesurgeon in reattaching soft tissue to bone. Thedevice includes anchors, manufactured of 96L/4DPLA copolymer + β-TCP and two (2), or three (3)Hi-Fi® sutures manufactured of polyethylene andpolypropylene. The device is bioabsorbable andis available in sizes between 4.5mm to 6.5mmand 17mm lengths. A disposable driver isincluded to implant the suture anchor.
Intended Use	The CrossFTTM Knotless Biocomposite SutureAnchor with Disposable Driver with DisposableDriver is intended to reattach soft tissue to bonein orthopedic surgical procedures.	The CrossFTTM-BC Suture Anchor is intended toreattach soft tissue to bone in orthopedic surgicalprocedures.
Indication for Use	The device 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 device 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	Pathological conditions of bone which wouldadversely affect the CrossFTTM KnotlessBiocomposite Suture Anchor with DisposableDriver with Disposable Driver. Pathological conditions in the soft tissue to berepaired or reconstructed which would adverselyaffect suture fixation.* Physical conditions that would eliminate, ortend to eliminate, adequate implant support orretard healing.* Conditions which tend to limit the patient'sability or willingness to restrict activities orfollow directions during the healing period.* Attachment of artificial ligaments or otherimplants.* Foreign body sensitivity, known or suspectedallergies to implant and/ or instrument materials	The CrossFTTM BC Suture Anchor iscontraindicated for the following orthopedicprocedures:- ACL (Anterior Cruciate Ligament), PCL(Posterior Cruciate Ligament), foot, and handprocedures

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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line.

	CrossFT™ Knotless Biocomposite SutureAnchor with Disposable DriverProposed	ConMed Linvatec CrossFT™-BC Suture Anchor(also known as: GENESYS™ CrossFT™ SutureAnchor)Predicate
	* This device is not approved for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine.
Components	Bioabsorbable anchorDisposable DriverSuture and/or Suture TapeThreader	Bioabsorbable anchorDisposable driverSuture

PERFORMANCE DATA

Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.

Completed testing includes the following:

Verification Testing

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

VIII. CONCLUSION

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFTTM BC Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is substantially equivalent to the CrossFTTM-BC Suture Anchor (K101100).

Validation Testing

User Validation
Packaging ●
Transportation ●

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.