The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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 Y-Knot™ All-Suture Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture construct. 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 all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.

AI/ML Overview

The provided text describes a medical device, the Y-Knot™ All-Suture Anchor, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics and clinical or analytical evaluations.

Instead, the document focuses on:

510(k) Summary: A regulatory submission outlining the device's characteristics and its equivalence to already marketed devices.
Device Description: What the device is made of and how it works.
Testing: A general list of testing performed (fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation, and side-by-side comparator qualifications), but no specific results or acceptance criteria are reported here.
Intended Use/Indications: For what medical purpose the device is designed.
Substantial Equivalence: The FDA's basis for clearing the device, comparing it to existing, legally marketed devices.

Therefore, I cannot provide the requested information from the given text. The text does not include:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria (e.g., minimum pull-out strength, maximum displacement under cyclic loading) are quantified.
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 their qualifications: Not applicable, as this is related to a cognitive assessment or diagnostic device, not a mechanical fixation device.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable in the context of performance metrics for a mechanical device. The ground truth for this device would be its physical behavior under stress, not a diagnostic finding.
Sample size for the training set: Not applicable, as this device does not involve a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

The "Testing" section broadly mentions various tests performed, such as "fixation strength" and "pull-out," which are likely mechanical tests to ensure the device performs as expected. However, the document provided is a summary of the 510(k) submission, and typically does not contain the detailed results, acceptance criteria, and methodologies of these tests. These details would be in the full submission, not in this public summary.

Summary

{0}------------------------------------------------

AUG - 8 2011

5. 510(k) Summary

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number _ K111779 .

Date Prepared: July 25, 2011

A. Submitter

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

B. Company Contact

Regulatory Contact: John Cusack Regulatory Affairs Manager (727) 399-5562 Telephone (727) 399-5264 Fax

C. Device Name

Trade Name:	Y-Knot™ All-Suture Anchor
Common Name:	Non-absorbable Suture Anchor System
Classification Name:	Fastener, Fixation, Nondegradable, Soft tissue
Proposed Class/Device:	Class II
Product Code:	MBI
Regulation:	21 CFR Part 888.3040

D. Predicate/Legally Marketed Devices

Device Name:	ConMed Linvatec Bio Mini Revo
Company Name:	ConMed Linvatec
510(k) #:	K053561
Device Name:	ConMed Linvatec Soft Tissue to Bone System
Company Name:	ConMed Linvatec
510(k) #:	K091549
Device Name:	Biomet JuggerKnot Soft Anchor
Company Name:	Biomet Sports Medicine
510(k) #:	K110145

{1}------------------------------------------------

E. Device Description

F. Testing

The verification and validation testing of the Y-Knot™ All-Suture Anchor includes fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation and side-by-side comparator qualifications.

G. Intended Use / Indications

H. Substantial Equivalence

The Y-Knot™ All-Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Bio Mini Revo (K053561), the ConMed Linvatec Soft Tissue to Bone System (K091549) and the Biomet JuggerKnot Soft Anchor (K110145).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

ConMed Linvatec % Mr. John Cusack Regulatory Affairs Manager 11311 Concept Boulevard Shelton, Connecticut 06484

Re: K111779

AUG - 8 2011

Trade/Device Name: Y-Knot™ All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: July 26, 2011 Received: July 27, 2011

Dear Mr. Cusack:

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. Iisting 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

{3}------------------------------------------------

Page 2 - Mr. John Cusack

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

111 779 (1/1)

6. Indications for Use

510(k) Number (if known):

Y-Knot™ All-Suture Anchor Device Name:

Indications for Use:

Prescription Use (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) M. Mill (Division Sign-Oft) (Division Sign-Off)
Division of Surgical, Of Surgical, Ofthopedic, Division of Sale
and Restorative Devices

510(k) Number

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.