The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.

AI/ML Overview

The provided text describes a medical device, the RIGIDLOOP™ Adjustable Cortical Fixation System, and its 510(k) summary for FDA clearance. This document type (510k summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance
Fixation Strength	Substantial equivalence to predicate device's fixation strength.	"Fixation strength testing (bench-top) was conducted. The testing demonstrated substantial equivalence of device performance."
Biocompatibility	Suitable for intended use without adverse biological reactions.	"The proposed device has been determined biocompatible for the intended use based on biocompatibility data."
Safety and Efficacy	Raise no new issues of safety and efficacy compared to predicate devices.	"The proposed device has raised no new issue of safety and efficacy."
Technological Characteristics	Substantial equivalence to predicate devices' technological characteristics (titanium button, non-absorbable sutures, adjustable suture).	"Technological characteristics and fixation strength are substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified. The document only states "Fixation strength testing (bench-top) was conducted." This implies an engineering test, not a clinical study with human subjects.
Data Provenance: Not specified, but likely laboratory/bench testing data rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of testing described. The "ground truth" for bench testing would be measured physical properties, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the described testing is bench-top, not a clinical study requiring adjudication of expert interpretations.

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:

This information is not applicable. The RIGIDLOOP™ system is a medical device for orthopedic surgery, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this device's clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The RIGIDLOOP™ system is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the fixation strength testing, the "ground truth" would be direct physical measurements of load, displacement, and failure points, consistent with engineering and biomechanical bench-top testing standards. For biocompatibility, it would be results from standardized biocompatibility assays.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training suture" mentioned in the description is for surgical training, not algorithm training.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above (not an AI/machine learning device).

Summary

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510(k) SUMMARY RIGIDLOOP™ Adjustable Cortical Fixation System

Date SummaryPrepared	February 7, 2014
Submitter'sName andAddress	Medos International SARLChemin-Blanc 38, Case PostaleCH 2400 Le Locle, Switzerland
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA	Telephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujimal@its.jnj.com
Name ofMedical Device	Trade Name:	RIGIDLOOPTM Adjustable Cortical Fixation System
	Common Name:	Fastener, fixation, nondegradable, soft tissue
DeviceClassification	MBI - Smooth or threaded metallic bone fixation fastener, classified as ClassII, regulated per 21 CFR 888.3040.Orthopedic panel
PredicateDevice	ToggleLoc System with ZipLoop Technology (K083070, K130033; BiometSports Medicine)Milagro Advance Interference Screw (K123362, DePuy Mitek)
Indications forUse	The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixationof soft tissue to bone in Femoral Cruciate Ligament Reconstruction.
DeviceDescription	The proposed device is a cortical fixation system composed of titanium button,adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leadingsuture (UHMWPE and green Polyester (PET) co-braid) and training suture(green PET). Length of the suture loops is adjustable to the desired length.The proposed device provides a fixation in cruciate ligament reconstructivesurgery. The device is provided as sterile for single patient use only.

Safety andPerformance	Non-clinical TestingFixation strength testing (bench-top) was conducted. The testing demonstratedsubstantial equivalence of device performance. The proposed device has beendetermined biocompatible for the intended use based on biocompatibility data.The proposed device has raised no new issue of safety and efficacy.
SubstantialEquivalence	The predicate devices have been used for the proposed indications. Theproposed device is a cortical fixation device that consists of a titanium buttonand non-absorbable sutures. Technological characteristics and fixation strengthare substantially equivalent to the predicate devices. Differences found betweenthe proposed and the predicate devices are considered minor and do not raisequestions concerning safety and efficacy.Based on the indications for use, technological characteristics and comparisonwith the predicate devices, we determined that the proposed device issubstantially equivalent to the predicate devices.

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Traditional 510(k) - RigidLoop Adjustable Cortical Fixation System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 7, 2014

Medos International Sárl % Ms. Yavoi Fujimaki DePuv Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K140324

Trade/Device Name: RIGIDLOOP™ Adjustable 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 4, 2014 Received: June 5, 2014

Dear Ms. Fujimaki:

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 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.

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Page 2 – Ms. Yayoi Fujimaki

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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 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 Industry and Consumer Education 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.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140324

Device Name

RIGIDLOOPTM Adjustable Cortical Fixation System

Indications for Use (Describe)

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Casey L. Hanley, Ph.D.
Division of Orthopedic Devices	Page 1/1

rvices (30) 443-6740 th PSC Publishing Page 003 - 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.