(81 days)
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 ioint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.
The provided text is a 510(k) Summary for a medical device called the "Y-Knot Flex All-Suture Anchor." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.
However, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of a device that uses AI. The provided document describes a physical medical device (a surgical suture anchor) and its associated testing, which are standard for mechanical medical devices (fixation strength, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation).
This document does not contain information about an AI-powered device, nor does it address AI-specific acceptance criteria, a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance, as requested in the prompt.
Therefore, I cannot fulfill most of the detailed requirements of your request based on the provided text.
I can, however, extract the information relevant to the testing performed for this specific non-AI device, which is analogous to a "study" for this type of product:
1. A table of acceptance criteria and the reported device performance:
The document states testing was performed but does not provide a specific table of acceptance criteria with corresponding performance values. It simply lists the types of tests conducted to demonstrate equivalence to the predicate device.
2. Sample sized 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 the tests nor the provenance of any data.
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):
Not applicable, as this is a mechanical device and "ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a mechanical device, "ground truth" would be established by engineering specifications, material properties, and biomechanical standards (e.g., pull-out strength measured against a predefined threshold). The document lists the types of tests done (fixation strength/pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation), implying these engineering and material standards serve as the "ground truth" or acceptance criteria.
8. The sample size for the training set:
Not applicable, as this is not an AI device and there is no "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of what can be extracted for this mechanical device:
- Device Name: Y-Knot Flex All-Suture Anchor, w/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm
- Predicate Device: Y-Knot™ All-Suture Anchor (K111779)
- Purpose of Testing: To demonstrate substantial equivalence to the predicate device.
- Types of Testing Performed (analogous to "study"):
- Fixation strength / pull-out
- Cyclic loading
- Insertion
- Biocompatibility
- Sterilization
- Shelf-life
- Packaging/transportation
The document does not provide quantitative acceptance criteria or detailed performance data for these tests, nor does it involve AI, expert consensus for ground truth, or MRMC studies.
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Image /page/0/Picture/1 description: The image shows the text 'K131035 (1/2)'. The text appears to be a code or identifier, possibly related to a document or item. The numbers and parentheses suggest it could be a reference number with a fraction indicating a part or page number. The text is in a simple, clear font.
Image /page/0/Picture/2 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized graphic on the left, followed by the word "CONMED" in large, bold letters. Below "CONMED" is the word "LINVATEC" in smaller letters. The logo appears to be for a medical or healthcare-related company.
Vincent Boulevard • Largo, FL 33773-4928 • 727-393-6464 • www.llmalac.com
510(k) Summary
JUL 0 2 2013
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
Date Prepared: 9 April 2013
A. Submitter
Linvatec Corporation d/b/a ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Joy Lovett Regulatory Affairs Specialist Telephone (727) 399-5137 Fax (727) 399-5264
C. Device Name
Trade Name: Y-Knot Flex All-Suture Anchor, w/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm Common Name: Non-absorbable Suture Anchor Classification Names: Fastener, Fixation, Nondegradable, Soft tissue Proposed Class/Device: Class II Product Codes: MBI 21 CFR Part 888.3040 Regulation
D. Predicate/Legally Marketed Devices
| Device Name: | Y-Knot™ All-Suture Anchor |
|---|---|
| Company Name: | Linvatec Corporation d/b/a ConMed Linvatec |
| 510(k) #: | K111779 |
Page 1 of 2
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Image /page/1/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo is in black and white and features the text "CONMED" in large, bold letters. Below the text is the word "LINVATEC" in smaller letters. To the left of the text is a stylized graphic.
K131035 (2/2)
1311 Concept Boulevard - Largo, FL 33773-4908 - 727-392-6464 - www.linvatec.com
E. Device Description
The Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.
F. Testing
The verification and validation testing of the Flexible Y-Knot All-Suture Anchor (Y1802) includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation.
G. Intended Use / Indications
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 ioint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
H. Substantial Equivalence
The Y-Knot Flex All-Suture Anchor 1.8mm (Y1802) is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Y-Knot® All-Suture Anchor (K111779) while raising no new issues of safety or effectiveness.
Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.
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
July 2, 2013
Linvatec Corporation d/b/a ConMed Linvatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K131035
Trade/Device Name: Y-KNOT® FLEX ALL-SUTURE ANCHOR, W/TWO #2 (5 metric) HI-FI SUTURES. 1.8mm Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 17, 2013 Received: May 22, 2013
Dear Ms. Lovett:
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
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Page 2 - Ms. Joy Lovett
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 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" (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.
Erining & eith
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
K131035 510(k) Number (if known): _
Device Name: Y-KNOT® FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 metric) HI-FI SUTURES, 1.8mm
Intended Use / Indications for Use:
The device 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 sulure anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of Orthopedic Devices
Module A - Page 13 of 26
§ 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.