DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DYNACORD™ Suture, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met for an AI device.

The document is for a non-AI medical device (surgical suture) and therefore does not discuss AI-specific metrics like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies (which are relevant to AI's impact on human readers).

However, I can extract the information that is present regarding the non-clinical testing performed for this suture, which serves as its performance and safety evaluation.

Here's the information I can provide based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from Non-clinical Testing)
USP Diameter	DYNACORD™ is oversized (meets USP requirements except for oversized diameter)
USP Knot Tensile Strength	Tested and results contributed to suitability for intended use
USP Needle Attachment	Tested and results contributed to suitability for intended use
in-vitro approximation force over time	Performance evaluated (specific quantitative results not provided)
Biocompatibility	Tested and found suitable
Sterility	Tested and found suitable
Shelf-life	Tested and found suitable
Bacterial Endotoxin	Meets endotoxin limits
in-vivo Efficacy Evaluation (GLP)	Found suitable for intended use
in-vivo Safety Evaluation (GLP)	Found suitable for intended use

Study Proving Device Meets Acceptance Criteria:

The document states: "Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits."

The conclusion is: "Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use."

Regarding AI-specific questions:

2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for this device.
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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or reference standards would be established by the standardized methods for each test (e.g., USP monographs for suture properties, recognized biocompatibility standards, sterility testing protocols, in-vivo animal model observations for efficacy and safety).
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 2, 2018

Medos International SARL DePuy Mitek, a Johnson and Johnson company % Ms. Tatyana Korsunsky Regulatory Affairs Technical Manager 325 Paramount Drive Raynham, Massachusetts 02767

Re: K181182

Trade/Device Name: DYNACORD™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 3, 2018 Received: July 5, 2018

Dear Ms. Korsunsky:

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, 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

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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.htm); 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.

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name DYNACORD™ Suture

Indications for Use (Describe)

DYNACORD suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

DYNACORD™ Suture

Date Prepared: June 27, 2018

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Tatyana KorsunskyRegulatory Affairs Technical ManagerDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: DYNACORD™ SutureClassification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)Common Name: Suture
SubstantialEquivalence	The DYNACORD™ Suture is substantially equivalent to:K021434, K041553 FiberWire® (Arthrex)Reference devices:K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International)K040004 ORTHOCORD® Suture (DePuy Mitek)
DeviceClassification	DYNACORD™ Suture is classified as:Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product code GAT, regulated under 21 CFR 878.5000.
DeviceDescription	DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™Suture has a double sheath and core design, and contains Ultra High MolecularWeight Polyethylene, Polyester and a Silicone/NaCl core.
TechnologicalCharacteristics	The DYNACORD™ Suture is a surgical suture, that meets USP except for oversizeddiameter.
	When DYNACORD™ Suture is placed in an aqueous environment, the salt particleswithin the silicone core elute out, leaving behind a micro-porous structure within thesilicone core. These small voids are consequently filled with surrounding fluid as thecore hydrates, resulting in a radial expansion of the suture. If laxity is present, thisradial expansion of the braid causes an axial shortening of the total suture length.The DYNACORD™ Suture is designed to resist laxity and minimize gap formation,by maintaining approximation force (compression).
Comparison tothe PredicateDevices	The DYNACORD™ Suture, similar to the predicate device FiberWire® (Arthrex,K021434, K041553), meets USP requirements for size 2 suture, except for oversizeddiameter. Both subject and predicate device have the same intended use of softtissue approximation. Both sutures contain UHMWPE and Polyester. FiberWire®(Arthrex) contains Silicone coating. DYNACORD™ Suture contains Silicone/NaClcore.
	The silicone/NaCl core is the main technological difference between theDYNACORD™ Suture and FiberWire® (Arthrex) Suture.
	The DYNACORD™ Suture is identical to the suture component of the referencepredicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture (K173859).
	The needles provided with DYNACORD™ Suture are also used with referencepredicate device ORTHOCORD®(K040004).
Indications forUse	DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissueapproximation, and/or ligation, including use with allograft tissue.
Non clinicalTesting	Performance testing included: USP Diameter (DYNACORD™ is oversized), USPKnot Tensile Strength, USP Needle Attachment, in-vitro approximation force overtime, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility,sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterialendotoxin testing has been completed and results have demonstrated that theproposed devices meet the endotoxin limits.
Safety andPerformance	Results of non-clinical testing have demonstrated that the proposed devices aresuitable for their intended use. Based on similarities in the indications for use,technological characteristics, and performance in comparison to the predicatedevice, the proposed DYNACORD™ Suture has shown to be substantiallyequivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

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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.