The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached non-absorbable fiber loop. This implantable fiber loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The device is offered in size ranges of 15-60mm in 5mm increments. Reamers and depth gauges are provided separately as reusable accessories to assist in the placement of the RIGIDLOOP Cortical Fixation System.

AI/ML Overview

The provided text describes the RIGIDLOOP Cortical Fixation System, a medical device for soft tissue to bone fixation, particularly for ACL repair. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through detailed clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way an AI/ML device would be evaluated.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in the provided document. However, I can extract information related to the device's performance assessment and substantial equivalence claims.

Here's a breakdown of the available information:

A table of acceptance criteria and the reported device performance
- The document does not provide explicit, quantitative acceptance criteria in the format typically seen for AI/ML device performance (e.g., minimum sensitivity, specificity, or AUC).
- Instead, the assessment is based on demonstrating "substantial equivalence" to predicate devices through comparisons of materials, design, and principal operation, supported by non-clinical testing.
- Reported Device Performance: The document states, "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." This is a qualitative statement of suitability rather than specific performance metrics against acceptance criteria.

Acceptance Criteria (Explicitly Stated in a Quantitative Manner)	Reported Device Performance (Quantitative Data)
Not explicitly stated in a quantitative manner. The acceptance is based on demonstrating substantial equivalence to predicate devices.	"Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." (Qualitative statement; no specific quantitative performance metrics provided.)

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The document describes "verification activities" and "testing assessments" but does not detail the sample sizes for these tests, nor their provenance, as these are non-clinical (mechanical, sterilization, biocompatibility) rather than clinical studies with patient data.
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)
- This information is not applicable/not provided for this type of device submission. The device is a mechanical implant, not an AI/ML diagnostic tool requiring expert-established ground truth from medical images or clinical data. "Ground truth" in this context would likely refer to engineering specifications and test results, not expert medical consensus on diagnostic interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/not provided. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in ground truth, which is not relevant for this device.
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
- This information is not applicable/not provided. The RIGIDLOOP Cortical Fixation System is a physical implant; it is not an AI algorithm that assists human readers/clinicians, so no MRMC study or AI assistance effect size is relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/not provided. This device is a mechanical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, "ground truth" would relate to the performance of the implant itself, evaluated through non-clinical testing. The document states "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility."
- Therefore, the "ground truth" would be established by engineering tests and standards (e.g., measuring pull-out strength against a specification, verifying sterility, confirming biocompatibility per standards).
The sample size for the training set
- This information is not applicable/not provided. There is no "training set" in the context of this device because it is not an AI/ML algorithm.
How the ground truth for the training set was established
- This information is not applicable/not provided. As above, there is no training set for this device.

Summary

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SECTION 2 - 510(k) SUMMARY RIGIDLOOP Cortical Fixation System

RecognizedManufacturer:	Medos International SarLPuits Godet 20CH 2000 NeuchâtelSwitzerland
Submitter:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: April 17, 2013
Contact Person	Kristine ChristoManager, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA
	AUG 1 2013Telephone: 508-828-3359Facsimile: 508-977-6911e-mail: KChristo@its.jnj.com
Name ofMedical Device	Proprietary Name: RIGIDLOOP Cortical Fixation SystemClassification Name: Fastener, Fixation, Nondegradable, Soft tissueCommon Name: Fastener, Fixation, Soft Tissue
SubstantialEquivalence	The RIGIDLOOP Cortical Fixation Systemis substantially equivalent to:• K980155 Smith & Nephew EndoButton Continuous Loop• K081098 Smith & Nephew EndoButton Continuous Loop• K060664 Fastin RC Anchors• K040004 / K042398 Orthocord suture
DeviceClassification	Smooth or threaded metallic bone fixation fastener, classified as Class II, product codeMBI regulated under 21 CFR 888.3040.

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DeviceDescription	The RIGIDLOOP Cortical Fixation System is a machined titanium implant designedto provide fixation in the repair of tendons and ligaments. It consists of a titaniumimplantable button with a pre-attached non-absorbable fiber loop. This implantablefiber loop has non-absorbable suture attached to the button for assisting in the buttonplacement and is discarded after the device placement. The device is offered in sizeranges of 15-60mm in 5mm increments.Reamers and depth gauges are provided separately as reusable accessories to assist inthe placement of the RIGIDLOOP Cortical Fixation System.
TechnologicalCharacteristics	The proposed RigidLoop Fixation Device consists of similar materials and design aspredicate Smith & Nephew Endobutton Cl (K980155, K081098). The proposed deviceprincipal operation is identical to predicate Smith &Nephew Endobutton CL(K980155, K081098). The RigidLoop Cortical Fixation Device has no newtechnological characteristics as compared to the predicate Smith &NephewEndobutton CL (K980155, K081098).
Indications forUse	The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue tobone in orthopedic procedures such as ACL repair.
Non clinicalTesting	Verification activities were performed on the implant and / or its predicates. Testingassessments include pull out testing, shelf-life, sterilization and biocompatibility.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.Based on the indications for use, technological characteristics, and comparison to thepredicate devices, the proposed RIGIDLOOP Cortical Fixation System has shown tobe substantially equivalent to the predicate devices under the Federal Food, Drug andCosmetic Act.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 1, 2013

DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K130814

Trade/Device Name: RigidLoop Cortical Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 27, 2013 Received: July 2, 2013

Dear Ms. Christo:

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 (2 1 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. Kristine Christo

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/ResourcesforYowIndustry/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/ReportalProblem/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 Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known): K130814 Device Name: RigidLoop Cortical Fixation System

Indications for Use:

The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedie . procedures such as ACL repair.

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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 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.