The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:

Procedure	Joint
Rotator Cuff Repair	Shoulder
Achilles Repair	Ankle
Bicep Tenodesis	Shoulder
Gluteus Medius Repair	Hip
Medial Patellofemoral Ligament (MPFL)	Knee

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 CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-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) Premarket Notification for a medical device, the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver. It states that the proposed device is substantially equivalent to a previously cleared predicate device (K170501) with the same name. Therefore, the information provided focuses on demonstrating this equivalence rather than establishing novel acceptance criteria or conducting studies to prove the device meets them from scratch.

However, based on the type of information typically required for such submissions and what is presented, we can infer some aspects and highlight what is not explicitly stated in terms of acceptance criteria and a detailed study report.

Here's an analysis based on the provided text, focusing on the requested categories:

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

The document does not present specific quantitative acceptance criteria in a table format, nor does it explicitly report numerical performance against such criteria. Instead, it states that "Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."

Inferred Performance/Criteria (based on "Verification Testing" and "Validation Testing"):

Acceptance Criteria Category	Reported Device Performance
Reliability	Met (implicitly, deemed substantially equivalent)
Ultimate Fixation Strength	Met (implicitly, deemed substantially equivalent)
Cyclic (Testing)	Met (implicitly, deemed substantially equivalent)
Sterilization	Met (implicitly, deemed substantially equivalent)
Pyrogenicity (Endotoxin)	Met the endotoxin limits
Biocompatibility	Met (implicitly, deemed substantially equivalent)
Shelf-life	Met (implicitly, deemed substantially equivalent)
User Validation	Met (implicitly, deemed substantially equivalent)
Packaging	Met (implicitly, deemed substantially equivalent)
Transportation	Met (implicitly, deemed substantially equivalent)
Clinical Performance (General)	"Test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the verification or validation tests. It also does not mention the country of origin or whether the data was retrospective or prospective. The statement about "clinical data in the literature" implies external, possibly previously published data, rather than specific new test set provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This entire section is not applicable to this type of device submission. This device is a surgical implant (suture anchor), not an AI/diagnostic software. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance. The "ground truth" for this device relates to its mechanical properties, biocompatibility, and sterilization, which are evaluated through laboratory and material testing.

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

This is not applicable as there is no diagnostic test set or expert adjudication process for this 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 is not applicable. This device is a 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 is not applicable. This device is a surgical implant without an algorithmic component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is typically defined by:

Engineering specifications and standards: These define acceptable ranges for mechanical strength, material composition, and dimensional accuracy.
Biocompatibility standards: ISO 10993 series and other relevant standards define acceptable biological responses to the materials.
Sterilization validation standards: These ensure the device is sterile according to established protocols.
Clinical literature: As indicated, "clinical data in the literature" was used to support the indications, implying that established clinical outcomes data informed the acceptability of the device's intended use and performance profile.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reason as above.

Summary

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August 29, 2017

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

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

Re: K171592

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: May 30, 2017 Received: May 31, 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

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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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 (DICE) 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 (DICE) 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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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)

K171592

Device Name

CrossFTM 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 the following orthopedic surgical procedures:

Procedure	Joint
Rotator Cuff Repair	Shoulder
Achilles Repair	Ankle
Bicep Tenodesis	Shoulder
Gluteus Medius Repair	Hip
Medial Patellofemoral Ligament (MPFL)	Knee

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, 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.

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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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"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 blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with the word "CORPORATION" in smaller blue letters underneath.

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 K171592

I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York 13502

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

Contact Person: Diana L. Nader-Martone Date Prepared: May 30, 2017

II. DEVICE NAME

Device Name:	CrossFTTM Knotless Biocomposite Suture Anchor with
	Disposable 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 DEVICE

Device Name:	CrossFT™ Knotless Biocomposite Suture Anchor with
	Disposable Driver
Company Name:	ConMed Corporation
510(k) #:	K170501

IV. DEVICE DESCRIPTION

V. INTENDED USE/ INDICATIONS FOR USE

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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. A blue line underlines the word "CONMED".

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:

Procedure	Joint
Rotator cuff repair	Shoulder
Achilles Repair	Ankle
Bicep Tenodesis	Shoulder
Gluteus Medius Repair	Hip
Medial Patellofemoral Ligament (MPFL)	Knee

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	CrossFTTM Knotless Biocomposite SutureAnchor with Disposable DriverPredicate
DeviceDescription	Same	The CrossFTTM Knotless Biocomposite SutureAnchor with Disposable Drivers are sterile, singleuse devices. The CrossFTTM KnotlessBiocomposite Suture Anchor with DisposableDrivers are 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.
Intended Use	The CrossFTTM Knotless Biocomposite SutureAnchor with Disposable Driver is intended toreattach soft tissue to bone in the followingorthopedic surgical procedures:Procedure Joint Rotator Cuff Repair Shoulder Achilles Repair Ankle Bicep Tenodesis Shoulder Gluteus Medius Repair Hip Medial Patellofemoral Ligament (MPFL) Knee		The CrossFTTM Knotless Biocomposite SutureAnchor with Disposable Driver is intended toreattach soft tissue to bone in orthopedic surgicalprocedures.
Indication for Use	Same	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.

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Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in bold, black letters. Below the word "CONMED" is the word "CORPORATION" in smaller, black letters. A thin blue line separates the two words.

	CrossFT™ Knotless Biocomposite SutureAnchor with Disposable DriverProposed	CrossFT™ Knotless Biocomposite SutureAnchor with Disposable DriverPredicate
Contraindications	Same	Pathological conditions of bone which wouldadversely affect the CrossFT™ 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.* This device is not approved for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine.
Components	Same	Bioabsorbable anchorDisposable DriverSuture and/or Suture TapeThreader

VII. PERFORMANCE DATA

Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor 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. The test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission.

Completed testing includes the following:

Verification Testing

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

● User Validation

Packaging .
Transportation ●

Validation Testing

VIII. CONCLUSION
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is identical in design, materials, principles of operation, and technical characteristics to the predicate, and substantially equivalent in intended use to the predicate. Based upon the findings of our performance testing, the difference regarding intended use presents no new issues of

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Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with the word "CORPORATION" in smaller blue letters underneath.

safety and efficacy, and the proposed, CrossFT™ Knotless Biocomposite Suture Anchor
with Disposable Driver is substantially equivalent to the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K170501).

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.