The Argo Knotless™ SP Anchor 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 tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

Device Description

The Argo Knotless™ SP Anchor is a soft tissue to bone fixation device that consists of a titanium tip with an eyelet to thread suture through, and a threaded anchor body, manufactured of PEEK material. The anchor design includes a 1.0mm UHMWPE Hi-Fi™ retention ribbon which secures the titanium tip to the delivery system and to the retention suture cleat.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Argo Knotless™ SP Anchor, a medical device used to reattach soft tissue to bone. It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML model.

The document focuses on demonstrating substantial equivalence of a physical medical device (suture anchor) to a previously cleared predicate device, through comparisons of manufacturing materials, intended use, and various performance tests. These tests are physical and mechanical in nature, not related to the performance of an AI/ML algorithm.

Thus, I cannot provide:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample size used for the test set and data provenance for an AI/ML device.
Number of experts used to establish ground truth and their qualifications for an AI/ML device.
Adjudication method for an AI/ML device.
MRMC study details or effect size for an AI/ML device.
Standalone performance details for an AI/ML device.
Type of ground truth used for an AI/ML device.
Sample size for the training set for an AI/ML device.
How ground truth for the training set was established for an AI/ML device.

Summary

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May 13, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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 Dionne Sanders, MS, CQA, RAC Senior Manager, Regulatory Affairs 525 French Road Utica, New York 13502

Re: K220757

Trade/Device Name: Argo Knotless™ SP Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 10, 2022 Received: March 15, 2022

Dear Dionne Sanders:

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/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For:

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220757

Device Name Argo Knotless™ SP Anchor

Indications for Use (Describe)

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

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)

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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 K220757.

I. SUBMITTER

Manufacturer: CONMED Corporation 525 French Road Utica, NY 13502

Official Contact Person: Dionne Sanders, MS, CQA, RAC 525 French Road Utica, NY 13502 (O) 813-997-8126

Date Prepared: May 13, 2022

II. DEVICE NAME

Device Name:	Argo Knotless™ SP Anchor
Classification Name:	Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class:	Class II, per 21 CFR Part 888.3040
Product Codes:	MBI

III. PREDICATE/ LEGALLY MARKETED DEVICE

Device Name:	CrossFT Knotless Suture Anchor
Company Name:	CONMED Corporation
510(k) #:	K163258

IV. DEVICE DESCRIPTION

V. INTENDED USE/ INDICATIONS FOR USE

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

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stabilizes the damaged 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.

	Proposed Device	Predicate Device
Manufacturer	CONMED	CONMED
Device Name	Argo KnotlessTM SP Anchor	CrossFT Knotless Suture Anchor
510k Number	TBD	K163258
IntendedUse/Indicationsfor Use	The non-absorbable sutureanchor is intended to reattachsoft tissue to bone inorthopedic surgical procedures.The Argo KnotlessTM SPAnchor may be used in eitherarthroscopic or open surgicalprocedures. After the suture isanchored to the bone, it may beused to reattach soft tissue,such as ligaments, tendons, orjoint capsules to the bone. Thesuture anchor system therebystabilizes the damaged tissue,in conjunction withappropriate postoperativeimmobilization throughout thehealing period.	The CrossFT Knotless Suture Anchorwith Disposable Driver is intended toreattach soft tissue to bone inorthopedic surgical procedures.The device may be used in eitherarthroscopic or open procedures.After the suture is anchored to thebone, it may be used to reattach softtissue, such as ligaments, tendons, orjoint capsules to the bone. The sutureanchor system thereby stabilizes thedamaged soft tissue, in conjunctionwith appropriate postoperativeimmobilization, throughout thehealing period.
Contraindications	1. Pathological conditions ofbone which would adverselyaffect the Argo KnotlessTM SPanchors.2. Pathological conditions inthe soft tissue to be repaired orreconstructed which wouldadversely affect suturefixation.3. Physical conditions thatwould eliminate, or tend toeliminate, adequate implantsupport or retard healing.4. Conditions which tend tolimit the patient's ability or	1. Pathological conditions of bonewhich would adversely affect theCrossFT Knotless Suture Anchor.2. Pathological conditions in the softtissue to be repaired orreconstructed which wouldadversely affect suture fixation.3. Physical conditions that wouldeliminate, or tend to eliminate,adequate implant support or retardhealing.4. Conditions which tend to limit thepatient's ability or willingness torestrict activities or follow
	willingness to restrict activitiesor follow directions during thehealing period.5. Attachment of artificialligaments or other implants.6. Foreign body sensitivity,known or suspected allergiesto implant and/or instrumentmaterials.7. This device is not approvedfor screw attachment orfixation to the posteriorelements (pedicles) of thecervical, thoracic or lumbarspine.	directions during the healingperiod.5. Attachment of artificial ligamentsor other implants.6. Foreign body sensitivity, known orsuspected allergies to implantand/or instrument materials.7. This device is not approved forscrew attachment or fixation to theposterior elements (pedicles) of thecervical, thoracic or lumbar spine.
How Supplied	Sterile Anchor w/Delivery System (1ea)
Single Use/Reusable	Single-Use Only
Sterilization	Device sterilized via Ethylene Oxide Sterilization - SAL (10-6)
Shelf-Life	18-months
Principle ofOperation	Non-absorbable suture anchors for soft tissue to bone fixation
Biocompatibility	In accordance with ISO 10993-1 and FDA# G95-1
Packaging	Packaged as a single unit device
Instrumentation	Reusable Bone PunchSterile Disposable Bone PunchDrill Bit
Suture	White UHMWPE, withpolyester dyed with D&C Blue#6	Black suture, Nylon withlogwood extract Blue suture, polyester per withD&C Blue #6, silicone coating Blue Suture, UHMWPE, dyedwith D&C Blue #6
Materials	Anchor: Titanium Tip; PEEKSuture: White, UHMWPEwith polyester dyed with D&CBlue #6Driver: Stainless SteelDriver Handle: Polycarbonate,ABS, RadelThreader: ABS, nitinol,stainless steel	Anchor: PEEKSuture: UHMWPE, Nylon, polyesterDriver Shaft and Tip: 17-7 StainlessSteel; 465 Stainless SteelHandle and Knob: PolycarbonateThreader: Polycarbonate, Nitinol
MRCompatibility	MR Conditional	MR Safe
PerformanceTesting	Reliability
	Cyclic Loading
	Insertion
	Fixation

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VII. PERFORMANCE DATA

Testing has been completed to demonstrate that the Argo Knotless™ SP 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:

Performance Testing Reliability Ultimate Fixation Strength Insertion Torque Cyclic Testing

Validation User Validation Packaging and Transportation Labeling Sterilization

Well-established Method Testing Pyrogen (Bacterial Endotoxin) Biocompatibility Shelf-life MR Safety Testing

VIII. CONCLUSION

The Argo Knotless™ SP Anchor is either substantially equivalent or identical in intended use, principles of operation, performance testing results, packaging, sterilization method, and biocompatibility as the predicate CrossFT Knotless Suture Anchors. Based upon the findings of our performance testing, the differences present no new issues of safety and effectiveness, and the Argo Knotless™ SP Anchors are substantially equivalent to the predicate device, CrossFT Knotless Suture Anchors (K163248).

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.