The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

Device Description

The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade stainless steel per ASTM 138. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

AI/ML Overview

This document is a 510(k) premarket notification for the "Frontier Medical Devices In-Line Orthopedic Cable Cerclage System." It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and device performance as one might find for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, and related elements will largely be absent or inapplicable in the context of this document. However, I can extract the relevant information that is present:

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

This document describes a medical device, not an AI or software algorithm. Therefore, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or accuracy for an AI system. The "performance" assessment is based on demonstrating substantial equivalence through non-clinical testing.

Acceptance Criteria (Implied)	Reported Device Performance (as stated in the 510(k) Summary)
Device performs in a manner substantially equivalent to predicate system concerning safety and effectiveness.	"Static and dynamic testing supports that the In-Line Orthopedic Cable Cerclage System performs in a manner substantially equivalent to that of the predicate system; no new issues of safety or effectiveness were raised."
No new types of safety or efficacy issues raised by technological characteristics.	"The minor differences in technological characteristics that do exist do not raise any new types of safety or efficacy issues."
No significant differences compared to predicates that would adversely affect product use.	"Any differences were not considered significant based on mechanical bench testing."

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

This document does not describe a test set or data provenance in the context of an AI/software study. The "testing" mentioned refers to mechanical bench testing of the physical medical device. The exact sample sizes or specific details of these non-clinical tests are not provided in this summary.

3. 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 is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm requiring expert ground truth for a diagnostic task.

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

This is not applicable for the reasons stated above.

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 is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.

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

This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.

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

For a physical device like this, "ground truth" relates to the mechanical properties and performance established through engineering standards and testing protocols (e.g., ASTM standards for material strength and fatigue testing). The specific details of these standards and results are not fully disclosed in this 510(k) summary but are fundamental to demonstrating substantial equivalence.

8. The sample size for the training set:

This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

January 13, 2016

Frontier Medical Devices, Inc. Allison Rogers Director of Regulatory Affairs 512 Fourth Street Gwinn, Michigan 49841

Re: K153242

Trade/Device Name: Frontier Medical Devices In-Line Orthopedic Cable Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: November 6, 2015 Received: November 9, 2015

Dear Ms. Rogers:

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 devicerelated 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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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/ResourcesforYou/Industry/default.htm. 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 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,

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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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 below.

510(k) Number (if known) K153242

Device Name

Frontier Medical Devices In-line Orthopedic Cable Cerclage System

Indications for Use (Describe)

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

In-Line Orthopedic Cable Cerclage System

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Traditional 510(k)

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510(k) Summary Pursuant to 21 CFR 807.92

Sponsor:	Frontier Medical Devices, Inc.512 Fourth StreetGwinn, MI 49841 USA
	Contact: Allison K. RogersPh: 906-232-1200Fx: 906-232-1222
	Prepared: November 4, 2015
Trade name:	Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
Common name:	Cerclage Cable System
Classification:	§888.3010 Bone Fixation Cerclage
Product Code:	JDQ
Panel/ Branch:	Orthopaedic and Rehabilitation Devices Panel; Panel Code 87
Predicates:	Frontier Medical Devices In-Line Orthopedic Cable Cerclage System(K151888)Zimmer Cable-Ready Cable Grip System (K935481 Pioneer Laboratories'Songer Cable System, K940729 Pioneer Laboratories' Bone Plate withCerclage Cable, K941213 Pioneer Laboratories' Songer Cable System)
Description:	The In-Line Orthopedic Cable Cerclage System consists of a cable andcrimp assembly to allow cerclage fixation of various long bone, pelvic andacetabular fractures as well as tension band fixation of the patella,olecranon, ankle and shoulder. The implants are manufactured frommedical grade stainless steel per ASTM 138. The implants are providedsterile. Instrumentation has been designed for use with this implantsystem.
Indications for Use:	The In-Line Orthopedic Cable Cerclage System is intended for use ingeneral orthopedic trauma surgery involving olecranon, patella, femur(including periprosthetic fractures), pelvic, acetabular, humeral, and anklefractures, acromioclavicular dislocations, prophylactic banding duringtotal joint procedures, and temporary reduction during open reductioninternal fixation (ORIF) procedures.
Non-ClinicalPerformance Data:	Static and dynamic testing supports that the In-Line Orthopedic CableCerclage System performs in a manner substantially equivalent to that ofthe predicate system; no new issues of safety or effectiveness were raised.
TechnologicalCharacteristics:	The In-Line Orthopedic Cable Cerclage System and predicate devices aresimilar in terms of indications for use, material composition, technologicalcharacteristics, design characteristics, and mechanical strength. The minordifferences in technological characteristics that do exist do not raise anynew types of safety or efficacy issues.
SubstantialEquivalence:	This submission supports the position that the subject In-Line OrthopedicCable Cerclage System is substantially equivalent to previously clearedsystems. There are no significant differences between the subject systemand the predicates which would adversely affect the use of the product.Any differences were not considered significant based on mechanicalbench testing.

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Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.