The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

Device Description

The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study proving the device meets those criteria. The provided text is a summary of safety and effectiveness for a medical device submitted to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study report with specific acceptance criteria and performance data.

Below is an attempt to extract and infer information based on the provided text, while also explicitly stating where information is not available in the document.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical targets or benchmarks for specific performance metrics. The document states that the device "performs as well as or better than the legally marketed predicate devices."	The device was determined to be "safe and effective and performs as well as or better than the legally marketed predicate devices."
Cyclic loading characteristics	Testing included cyclic loading characteristics. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported.
Ultimate fixation strength of meniscal repairs	Testing included ultimate fixation strength. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported.
Functional system testing	Testing included functional system testing. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported.
Material degradation	Testing included material degradation. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported.
Risk analysis	A risk analysis was conducted. The implication is that risks were adequately identified and mitigated.
Packaging/transportation qualification	Packaging/transportation qualification was conducted. The implication is that the packaging and transportation methods adequately protect the device.
Substantial Equivalence to Predicate Devices	The device is "substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics" to predicate devices (Meniscal Cinch™ K073149 and Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems K072322). Minor differences "do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use."

Detailed Study Information:

The provided document describes the general types of testing conducted but does not provide details about a specific study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've requested for a device performance study. The core of a 510(k) submission for substantial equivalence is often bench testing and comparison to predicates, as opposed to a full clinical trial with "ground truth" as typically defined for diagnostic or AI-driven devices.

Here's a breakdown of the specific points you requested, with clarification on what is and isn't available:

A table of acceptance criteria and the reported device performance:
- As seen in the table above, explicit numerical acceptance criteria, specific thresholds, or detailed performance metrics from the testing (e.g., "cyclic loading withstood X cycles with Y force") are not provided in this 510(k) summary. The summary broadly states that testing showed the device "performs as well as or better than" predicates and is "safe and effective."
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "verification and validation testing including cyclic loading characteristics, ultimate fixation strength," etc., but does not provide details on the number of samples tested for each type of bench testing, nor does it refer to clinical data or its provenance. This is typical for a device like a surgical instrument/implant in a 510(k) where substantial equivalence is often shown through engineering validation and comparison to existing devices.
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/Not specified. The "ground truth" concept, especially in the context of expert consensus, is more relevant for diagnostic devices or AI algorithms that interpret medical data. For a mechanical surgical device like the Sequent™ Meniscal Repair Device, "ground truth" would be established through objective physical measurements (e.g., force, displacement, cycles) in benchtop testing, or potentially by surgical outcomes if clinical trials were cited (which they are not in this summary). There's no mention of expert readers or consensus to establish ground truth for this type of device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving human interpretation or clinical endpoints. This summary describes engineering and performance testing.
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 device is a surgical repair device, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical tool and implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As inferred from the "Testing" section, the "ground truth" for this device would be based on objective engineering and biomechanical measurements relevant to its function, such as:
  - Measurements of cyclic loading endurance.
  - Measurements of ultimate fixation strength.
  - Measurements of material degradation (e.g., tensile strength loss over time).
  - Functional assessments of the device's deployment mechanism.
- The document implies that these measurements were compared against either internal specifications or the performance of predicate devices.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this device is not an AI or machine learning model.
How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device.

In summary, the 510(k) summary for the ConMed Linvatec Sequent™ Meniscal Repair Device demonstrates substantial equivalence primarily through bench testing comparing its performance (cyclic loading, fixation strength, etc.) to legally marketed predicate devices. It does not provide the granular data or study design details for "acceptance criteria" and "ground truth" in the way one would expect for a diagnostic or AI-powered medical device. The "acceptance criteria" appear to be broadly defined by the performance of the predicate devices and general safety and effectiveness standards for such implants.

Summary

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510(k) SUMMARY ConMed Linvatec

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 the 510(k) Number < 102 3.3 9

Date Prepared: August 12, 2010 Date Revised: November 5, 2010

A. Submitter

NOV 2 3 2010

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

B. Company Contact

Jan Flégeau Regulatory Affairs Manager (727) 399-5433 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	ConMed Linvatec Sequent™ Meniscal Repair Device
Common Name:	Suture Retention Device
Classification Name:	Nonabsorbable poly(ethylene terephthalate) surgical suture.
Proposed Class/Device:	Class II
Product Code:	GAT
Regulation:	21 CFR Part 878.5000

D. Predicate/Legally Marketed Devices

Device Name:	Meniscal Cinch™
Company Name:	Arthrex Inc.
510(k) #:	K073149
Device Name:	Ultra Fast-Fix and Ultra Fast-Fix AB MeniscalRepair Systems
Company Name:	Smith & Nephew
510(k) #:	K072322

ર-I

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E. Device Description

F. Intended Use

G. Testing

ConMed Linvatec conducted verification and validation testing including cyclic loading characteristics, ultimate fixation strength of meniscal repairs, functional system testing, material degradation, risk analysis and packaging/transportation qualification. Based on this testing, we have determined that the device is safe and effective and performs as well as or better than the legally marketed predicate devices identified in Section D of this summary.

H. Substantial Equivalence

The ConMed Linvatec Sequent™ Meniscal Repair Device is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices.

Minor differences between the ConMed Linvatec Sequent™ Meniscal Repair Device and the predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

ConMed Linvatec % Ms, Jan Flegeau Regulatory Affairs Manager 1311 Concept Boulevard Largo, Florida 33773

NOV 2 3 2010

Re: K102339

Trade/Device Name: ConMed Linvatec Sequent™ Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, MBI Dated: November 19, 2010 Received: November 22, 2010

Dear Ms. Flegeau:

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.

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. Jan Flegeau

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,

barbare Buett

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

Enclosure

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Indications for Use

K102339 510(k) Number (if known): ___

Device Name: ConMed Linvatec Sequent™ Meniscal Repair Device

NOV 2 3 2010

Indications for Use:

Prescription Use_X_AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onetu for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102339

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.