(103 days)
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.
The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
The provided text describes a 510(k) premarket notification for a medical device called "TruShot™ with Y-Knot® All-Suture Anchor". It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for an AI/device algorithm in the way your request specifies.
The document discusses performance data in the context of device safety and efficacy and substantial equivalence to a predicate device, not in the terms of a novel AI algorithm's performance. Therefore, many of the requested elements (sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone AI performance, training set size, and ground truth establishment for training set) are not applicable or extractable from this document.
However, I can extract the general acceptance criteria (testing types) and a general statement about device performance.
Here's the information that can be extracted from the provided text, recognizing the limitations of the document relative to your detailed request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Testing Category) | Reported Device Performance |
|---|---|
| Reliability | Performed as intended |
| Ultimate Fixation Strength | Performed as intended |
| Cyclic | Performed as intended |
| Sterilization | Performed as intended |
| Pyrogen (Bacterial endotoxin testing) | Met the endotoxin limits |
| Biocompatibility | Performed as intended |
| Shelf-life | Performed as intended |
| Post Aging Functional Testing | Performed as intended |
| MR Safety Testing | Performed as intended |
| User Validation | Performed as intended |
| Packaging | Performed as intended |
| Transportation | Performed as intended |
2. Sample size used for the test set and the data provenance
Not explicitly stated for specific tests. The document refers to "testing" in a general sense, not specific to a "test set" for an algorithm. This is a traditional medical device submission, not an AI/ML submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. "User Validation" is mentioned, implying human interaction, but details on the number or qualifications of users/experts involved in this validation are absent.
4. Adjudication method for the test set
Not applicable based on the provided document.
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. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For a traditional medical device like a suture anchor, "ground truth" would typically refer to established biomechanical properties, material standards, and clinical outcomes for similar devices. The document implies compliance with these through the various verification and validation tests listed. Pathology or outcome data are not specified as direct ground truth for these tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and thus no "training set" in that context is mentioned.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 19, 2018
CONMED Corporation Diana L. Nader-Martone, M.S. Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182446
Trade/Device Name: TruShot™ with Y-Knot® All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 16, 2018 Received: November 20, 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/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, 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
{1}------------------------------------------------
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 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 (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 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
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K182446
Device Name TruShot™ with Y-Knot® All-Suture Anchor
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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract design on the left. To the right of the square, the word "CONMED" is written in bold, black letters. Below "CONMED", the word "CORPORATION" is written in smaller, black letters.
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 K182446.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5425 Fax: 727-399-5264
Contact Persons: Diana L. Nader-Martone or Kathy Reddig Date Prepared: September 6, 2018
II. DEVICE NAME
| Device Name: | TruShot™ with Y-Knot® All-Suture Anchors |
|---|---|
| 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: | ConMed Linvatec Y-Knot™ All-Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K111779 |
IV. REFERENCE DEVICE
| Device Name: | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi |
|---|---|
| Sutures, 1.8mm | |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K131035 |
V. DEVICE DESCRIPTION
The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape inside, resembling a stylized "C". To the right of the square is the word "CONMED" in bold, black letters. Below "CONMED" is the word "CORPORATION" in smaller, lighter letters, underlined with a blue line.
needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
VI. INTENDED USE/ INDICATIONS FOR USE
The non-absorbable suture anchors are 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.
VII. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| TruShotTM with Y-Knot® All-Suture AnchorProposed Device | ConMed Linvatec Y-Knot® All-Suture AnchorPredicate Device | Y-Knot Flex All-Suture Anchor,w/Two #2 (5 Metric) Hi-FiSutures, 1.8mmReference Device | |
|---|---|---|---|
| DeviceDescription | The non-absorbable suture anchorsare intended to reattach soft tissueto bone in orthopedic surgicalprocedures. | Same | Same |
| Intended Use | The non-absorbable suture anchorsare intended to reattach soft tissueto bone in orthopedic surgicalprocedures. | Same | Same |
| Indication for Use | The system may be used in eitherarthroscopic or open surgicalprocedures. After the suture isanchored to the bone, it may beused to reattach soft tissue, such asligaments, tendons, or jointcapsules to the bone. The sutureanchor system thereby stabilizesthe damaged soft tissue, inconjunction with appropriatepostoperative immobilization,throughout the healing period. | Same | Same |
| Contraindications | 1. Pathological conditions of bonewhich would adversely affectthe Y-Knot 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, | Same | Same |
{5}------------------------------------------------
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, the word "CONMED" is written in a bold, black font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, black font.
| TruShot™ with Y-Knot® All-Suture AnchorProposed Device | ConMed Linvatec Y-Knot® All-Suture AnchorPredicate Device | Y-Knot Flex All-Suture Anchor,w/Two #2 (5 Metric) Hi-FiSutures, 1.8mmReference Device | |
|---|---|---|---|
| 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, knownor suspected allergies to implantand/or instrument materials.7. This device is not approved forscrew attachment or fixation tothe posterior elements (pedicles)of the cervical, thoracic orlumbar spine.8. Patients with active sepsis orinfection. | |||
| Components | All-Suture AnchorDisposable Guide HandleSuture | All-Suture AnchorDisposable DriverSuture | All-Suture AnchorDisposable DriverSuture |
| TechnologicalCharacteristics | Flat-braid suture anchor | Flat-braid suture anchor | Flat-braid suture anchor |
| One or two #2 suturesDrilled pilot hole | One #2 sutureDrilled pilot hole | Two #2 suturesDrilled pilot hole | |
| Press-fit insertion | Press-fit insertion | Press-fit insertion | |
| Expandable design | Expandable design | Expandable design |
VIII. PERFORMANCE DATA
Testing has been completed to demonstrate that the TruShot™ with Y-Knot® All-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:
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 .
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. 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 a bold, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.
IX. CONCLUSION
The TruShot™ with Y-Knot® All-Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Y-Knot™ All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the TruShot™ with Y-Knot® All-Suture Anchor is substantially equivalent to the ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779).
N/A