Indications for Use: 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 CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver. It asserts that the device is substantially equivalent to a predicate device. However, it does not contain a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than providing detailed performance studies with acceptance criteria for a new, non-equivalent device.

Here's a breakdown of why the requested information cannot be fully extracted and what is available:

The document lists various "Verification Testing" and "Validation Testing" that were completed. These tests are implicitly meant to demonstrate that the new device performs as intended and is substantially equivalent. However, specific acceptance criteria for each test (e.g., minimum ultimate fixation strength in Newtons) and the quantitative results are not provided in this summary.

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: While types of tests are listed (e.g., Ultimate Fixation Strength, Cyclic), the specific numerical acceptance criteria for these tests and the device's measured performance against them are not included.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and testing. These are mechanical/biological performance tests, not AI-driven diagnostic studies requiring expert ground truth.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical medical device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not directly applicable in the sense of expert consensus or pathology for an AI device. The "ground truth" for these engineering tests would be established by standardized testing methods and measurement against predefined specifications based on the predicate device or industry standards.
The sample size for the training set: Not applicable (not an AI device).
How the ground truth for the training set was established: Not applicable (not an AI device).

Information that can be inferred or directly stated from the text:

While a table of acceptance criteria and performance data is not explicitly given, the document states that "Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread Suture Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits." This implies that acceptance criteria were met, even if not detailed here.

General Purpose/Type of Device:
The device is a CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver, intended to reattach soft tissue to bone in orthopedic surgical procedures.

Predicate Device:
The predicate device is the CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258) by ConMed.

Studies Conducted (as listed):

Verification Testing:
- Reliability
- Ultimate Fixation Strength
- Cyclic
- Sterilization
- Pyrogen
- Biocompatibility
- Shelf-life
- Post Aging Functional Testing
- MR Safety Testing
Validation Testing:
- User Validation
- Packaging
- Transportation

Conclusion stated regarding performance:
"The CrossFTTM Knotless Deep Thread Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258)."

In summary, the provided document from the FDA 510(k) process states that various performance tests were completed and that these tests demonstrated substantial equivalence to a predicate device, meaning the new device "performs as intended" and met necessary safety and efficacy benchmarks. However, it does not provide the specific quantitative acceptance criteria or detailed results of these tests, which are typically found in the full submission, not the summary document.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 4, 2019

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

Re: K182621

Trade/Device Name: CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 30, 2018 Received: December 6, 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 may, 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 aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/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, 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

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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 medical devices and radiation-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,

Laurence D. Coyne -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

510(k) Number (if known)

K182621

Device Name

CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver

Indications for Use (Describe)

Intended Use

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

Indications for Use

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 suture anchor systems thereby stabilize 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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Image /page/3/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, the word "CONMED" is written in a bold, black font, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in a smaller, lighter font.

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 K182621

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: September 21, 2018

II. DEVICE NAME

Device Name:	CrossFT™ Knotless Deep Thread Suture Anchor withDisposable Driver
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:	CrossFT™ Knotless Suture Anchor with Disposable Driver
Company Name:	ConMed
510(k)#:	K163258

IV. REFERENCE/ LEGALLY MARKET DEVICE

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

V. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, resembling a curved shape. To the right of the graphic is the company name, "CONMED," in bold, black letters. Below the company name is the word "CORPORATION" in smaller, black letters.

INTENDED USE/ INDICATIONS FOR USE VI.

The non-absorbable suture anchor 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.

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.

	CrossFT™ Knotless Deep ThreadSuture Anchor with DisposableDriverProposed Device	CrossFT™ Knotless SutureAnchor with DisposableDriverPredicate Device	ConMed Linvatec Soft Tissueto Bone System(CrossFT™ Suture Anchorwith Disposable Driver)Reference
Device Description	The CONMED CrossFT™Knotless Deep Thread SutureAnchors are manufactured fromstable PolyEtherEtherKetone(PEEK). The CrossFT KnotlessDeep Thread Anchors are athreaded screw-in suture anchordesign. The CrossFT™ KnotlessDeep Thread Suture Anchors areprovided sterile, preloaded on asingle-use driver and someinclude a preloaded sliding #2 (5metric) Hi-Fi® Suture. Thedevice is EO sterilized.	The CONMED CrossFT™Knotless Deep Thread SutureAnchors are manufacturedfrom stablePolyEtherEtherKetone(PEEK). The CrossFTKnotless Deep ThreadAnchors are a threaded screw-in suture anchor design. TheCrossFT™ Knotless DeepThread Suture Anchors areprovided sterile, preloaded ona single-use driver and someinclude a preloaded sliding #2(5 metric) Hi-Fi® Suture. Thedevice is EO sterilized.	Reference
Intended Use	The non-absorbable suture anchorsare intended to reattach soft tissueto bone in orthopedic surgicalprocedures.	Same	Same
Indication for Use	The device may be used in eitherarthroscopic or open surgicalprocedures. After the suture isanchored to the bone, it may beused to reattach soft tissue, suchas ligaments, tendons, or jointcapsules to the bone. The sutureanchor system thereby stabilizesthe damaged soft tissue, inconjunction with appropriatepostoperative immobilization,throughout the healing period.	Same	Same
	CrossFT™ Knotless Deep ThreadSuture Anchor with DisposableDriverProposed Device	CrossFT™ Knotless SutureAnchor with DisposableDriverPredicate Device	ConMed Linvatec Soft Tissueto Bone System(CrossFT™ Suture Anchorwith Disposable Driver)Reference
Contraindications	1. Pathological conditions of bonewhich would adversely affectthe CrossFT™ Knotless DeepThread Suture Anchor.2. Pathological conditions in thesoft tissue to be repaired orreconstructed which wouldadversely affect suture fixation.3. Physical conditions that wouldeliminate, or tend to eliminate,adequate implant support orretard healing.4. Conditions which tend to limitthe patient's ability orwillingness to restrict activitiesor follow directions during thehealing period.5. Attachment of artificialligaments or other implants.6. Foreign body sensitivity,known or suspected allergies toimplant and/or instrumentmaterials.7. This device is not approved forscrew attachment or fixation tothe posterior elements(pedicles) of the cervical,thoracic or lumbar spine.8. Patients with active sepsis orinfection.	Same	Same
Components	Non-absorbable AnchorDisposable DriverThreaderSuture (some catalog numbers)	Non-absorbable AnchorDisposable DriverThreaderSuture (some catalognumbers)Suture Tape (some catalognumbers)	Non-absorbable AnchorDisposable DriverSuture
TechnologicalCharacteristics	Non-absorbable,PolyEtherEtherKetone (PEEK)AnchorScrew-in, Knotless AnchorDesignThreaderDisposable Driver	Same	Non-absorbable,PolyEtherEtherKetone(PEEK) AnchorScrew-in Anchor DesignDisposable Driver

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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" shape inside. To the right of the square is the word "CONMED" in black, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, sans-serif font.

PERFORMANCE DATA

Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread Suture Anchor performs 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:

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Image /page/6/Picture/0 description: The image shows the Conmed Corporation logo. 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.

K182621 Page 4 of 4

Verification Testing

Reliability ●
Ultimate Fixation Strength ●
Cyclic ●
Sterilization ●
Pyrogen ●
Biocompatibility
Shelf-life
Post Aging Functional Testing ●
MR Safety Testing ●

VIII. CONCLUSION

The CrossFTTM Knotless Deep Thread Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258).

Validation Testing

User Validation ●
Packaging ●
Transportation ●

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.