The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Device Description

The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a disposable inserter. The suture anchors are constructed of a flat suture that is interlaced longitudinally along its central width by double and triple suture strands. The flat suture and the double and tripled loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable inserter has a stainless steel shaft supporting the forked shaped tip, and a polycarbonate handle. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. The finished device is provided sterile, for single use.

The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures features both surgical techniques for self-punching and pre-drill pilot hole insertion.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific performance acceptance criteria in the manner of an AI/ML device.

Here's an analysis based on the information provided, highlighting why it doesn't directly fit the AI/ML device study criteria:

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

The document does not explicitly state quantitative acceptance criteria or reported device performance in a comparative table format as might be expected for an AI/ML device. Instead, it lists the types of testing performed to demonstrate safety and effectiveness for a surgical anchor:

Acceptance Criteria Type	Reported Device Performance (Implicitly Met)
Fixation strength / pull-out	Tested (implied to meet requirements for substantial equivalence)
Cyclic loading	Tested (implied to meet requirements for substantial equivalence)
Insertion	Tested (implied to meet requirements for substantial equivalence)
Biocompatibility	Tested (implied to meet requirements for substantial equivalence)
Sterilization	Tested (implied to meet requirements for substantial equivalence)
Shelf-life	Tested (implied to meet requirements for substantial equivalence)
Packaging/transportation	Tested (implied to meet requirements for substantial equivalence)

The core "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate device. This means the new device is as safe and effective as the legally marketed predicate. The tests performed are to support this claim.

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 sample sizes for any of the tests (e.g., number of anchors tested for pull-out strength). It also does not mention data provenance (country of origin, retrospective/prospective) because the tests described are bench and lab tests on the physical device, not clinical data involving human subjects or real-world usage data in the context of AI/ML.

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 section is not applicable. The "ground truth" for a physical device like a surgical anchor is based on engineering specifications, material science, and biomechanical performance standards, not expert clinical interpretation of data.

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

This is not applicable for a physical medical device's verification and validation testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation.

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 not an AI/ML diagnostic or assistive tool that would involve "human readers" or "AI assistance."

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

This is not applicable as the device is not an algorithm.

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

The "ground truth" for this device's performance would be defined by engineering specifications, biomechanical standards, and material properties that ensure its function (e.g., strength, durability, biocompatibility) is consistent with its intended use and equivalent to the predicate device. This is established through the specific tests listed (fixation strength, cyclic loading, etc.).

8. The sample size for the training set

This is not applicable. This device does not involve a "training set" as it is a physical surgical implant, not an AI/ML algorithm.

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

This is not applicable for the reason stated above.

In Summary:

The provided document details a 510(k) submission for a non-absorbable suture anchor. The "study" referenced is the verification and validation testing of the device, which aims to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device. The criteria for demonstrating this are based on established engineering and biocompatibility standards for surgical implants, not on AI/ML performance metrics, clinical reader studies, or data provenance in the way one would describe a software-based AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.

JAN - 3 2014

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

Date Prepared: December 31, 2013

A. Submitter

ConMed Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

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

C. Device Name

Trade Name:	Y-Knot® RC All-Suture Anchor w/Two and Three #2Hi-Fi® Sutures
Common Name:	Non-absorbable Suture Anchor
Classification Names:	Fastener, Fixation, Nondegradable, Soft tissue
Proposed Class/Device:	Class II
Product Codes:	MBI
Regulation	21 CFR Part 888.3040

D. Predicate/Legally Marketed Devices

Device Name:	Y-Knot® Flex All-Suture Anchor, w/two #2 (5 Metric)
HI-FI® Suture, 1.8mm
Company Name:	Linvatec Corporation d/b/a ConMed Linvatec
510(k) #:	K131035

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Image /page/1/Picture/1 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized graphic to the left of the word "CONMED" in large, bold letters. Below "CONMED" is the word "CORPORATION" in smaller letters. The graphic is a curved shape, possibly representing a medical device or tool.

E. Device Description

The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures features both surgical techniques for self-punching and pre-drill pilot hole insertion.

A breakdown of catalog numbers, description and suture configuration is included in Table 1.

CatalogNumber	Description	Suture Configuration
YRC02	Y-Knot® RC All-Suture Anchor w/two#2 Hi-Fi®	1 Blue and 1 White/Black
YRC03	Y-Knot® RC All-Suture Anchor w/three#2 Hi-Fi®	1 Blue, 1 White/Black and 1White/Blue
YRC02A	Y-Knot® RC All-Suture Anchor w/two#2 Hi-Fi®	1 White/Black and 1 White/Blue
YRC03A	Y-Knot® RC All-Suture Anchor w/three#2 Hi-Fi®	1 White/Black, 1 White/Blue and1 White

Table 1 : Y - Knot® RC All-Suture Anchors

The Y-Knot® RC All-Suture Anchors are inserted using the following instrumentation.

Catalog Number	Description
Y28D	Y-Knot® RC Disposable Drill Bit, 2.8mm
Y-DBP28	Y-Knot® RC Disposable Broaching Punch, 2.8mm
Y-BP28	Y-Knot® RC Broaching Punch, 2.8mm
Y-DGRC	Y-Knot® RC Drill Guide
Y-OBRC	Y-Knot® RC Drill Guide Obturator

Table 2: Description of Instrumentation

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Image /page/2/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white.

F. Testing

The verification and validation testing of the Y-Knot® RC All-Suture Anchor w/two and three #2 Hi-Fi® Sutures includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation testing.

G. Intended Use / Indications

H. Substantial Equivalence

The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® are substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Y-Knot® Flex All-Suture Anchor, w/two #2 (5 Metric) HI-FI® Suture, 1.8mm and raises no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 3, 2014

ConMed Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

Re: K133224

Trade/Device Name: Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 20, 2013 Received: December 23, 2013

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

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Page 2 – Ms. Nyrobia Freeman

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Ronalding Jean -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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Indications for Use

510(k) Number (if known): _K133224

Device Name: Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures

INTENDED USE

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

INDICATIONS FOR USE

The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/12 description: The image shows the words "Casey L. Hanley, Ph.D." on the top line, followed by a horizontal line. The second line says "Division of Orthopedic Devices". The text is in a simple, sans-serif font and is easy to read.

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.