Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

AI/ML Overview

The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.

Instead of a detailed study with acceptance criteria and performance metrics, it states that:

"The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
"Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."

This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.

However, I can extract the following limited information:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance
Conformance to Standards	Conformed to consensus and voluntary standards.
USP Monograph for Absorbable Sutures	Conformed to the USP monograph for absorbable sutures, except for oversized diameter. (The specific parameters within the USP monograph are not detailed, nor is the extent of the oversized diameter mentioned).
Material Composition	Comprised of the same materials as the predicate Size 2 Orthocord suture (K040004/K043298).
Design Similarity	Similar design to the predicate Size 2 Orthocord suture (K040004/K043298), with differences in size and braid construction.

2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not mentioned for this type of submission.

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 device is a surgical suture, not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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

K123668 page 1/2

SECTION 2 - 510(k) SUMMARY

Small Size Orthocord® Suture

FEB 2 6 2013

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Tatyana KorsunskyRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA
	Telephone: 508-828-3122Facsimile: 508-977-6911e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: ORTHOCORD®Classification Name: Suture, surgical, absorbable, polydioxanone;Suture, nonabsorbable, synthetic, polyethyleneCommon Name:Suture
SubstantialEquivalenceFacility	The Small Size Orthocord® Suture is substantially equivalent to:• K040004: Orthocord® Suture (USP Size 2, Violet) (April 13, 2004)• K043298: Orthocord® Suture (USP Size 2, Blue) (Dec 10, 2004)• K071257: Minilok Anchor with #2-0 Orthocord® Suture (Jun 29, 2007)• K080352: Microfix Anchor with #3-0 and 4-0 Orthocord® Suture (Mar 12, 2008)• K946173: Ethibond Suture (January 09, 1995)• K022715: Vicryl Suture (December 19, 2002)• K122374, K071622, K041553: Fiberwire FiberLoop Suture (September 25, 2012;July 03, 2007; December 10, 2004)
DeviceClassification	Class II:• Sec. 878.4840 Absorbable polydioxanone surgical suture, product code NEW;• Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture,product code GAT.
DeviceDescription	Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed(D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of90% caprolactone and 10% glycolide.
Indications forUse	ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/orligation, including orthopaedic procedures.
Safety andPerformance	The determination of substantial equivalence for this device was based on a detaileddevice description, and conformance to consensus and voluntary standards. Non-clinical laboratory testing was performed demonstrating that the device conformed tothe USP monograph for absorbable sutures, except for oversized diameter.The proposed Small Size Orthocord sutures are comprised of the same materials andare similar design to the predicate Size 2 Orthocord suture (K040004/K043298) withdifferences in size and braid construction. The proposed device, Small Size Orthocord,is currently offered in an anchor configuration of the DePuy Mitek's Minilok(K071257) and Microfix (K080352) anchors.Based on the indications for use, technological characteristics, and comparison topredicate devices, the ORTHOCORD suture has been shown to be substantiallyequivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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

K123668 page 2/2

Small Size Orthocord Suture Sizes and Configurations: Size 0 Orthocord Suture; (single armed) Size 2-0 Orthocord Suture; (single armed) Size 3-0 Orthocord Suture; (single armed) Size 4-0 Orthocord Suture; (single armed) Size 4-0 Orthocord Suture in a Loop (both ends of suture swaged to one needle)

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

DePuy Mitek Incorporated., A Johnson and Johnson Company % Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts, 02767

Letter dated: February 26, 2013

Re: K123668

Trade/Device Name: Small Size ORTHOCORD® Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW, GAT Dated: January 24, 2013 Received: January 28, 2013

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Tatyana Korsunsky

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N.Melkerson -S

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

Enclosure

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

Indications for Use

510(k) Number (if known): K123668 Device Name: Small Size ORTHOCORD® Suture Indications for Use:

The Small Size ORTHOCORD® Suture is indicated for:

ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kraúse

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123668 :

Page 1 of_1

22 | P a g e

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.