Intended for use in femur and tibia fractures, prophylactic banding, trochanteric reattachment, olecranon fractures, patella fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing techniques, sternum fixation after open chest surgery and stabilization of cortical onlay strut grafts.

Device Description

The new Peri-Prosthetic Cabling system consists of cables, crimp lugs (cable sleeves) and associated instrumentation. The cables and crimp lugs are made of cobalt chromium alloy. All cables have a 7x7 strand construction, with the overall cable having a 1.8mm diameter.

AI/ML Overview

The provided text describes a medical device called the "Peri-Prosthetic Cabling System" (K133354) and its substantial equivalence to a predicate device. It details the device's technical characteristics, indications for use, and a summary of the pre-clinical data used to establish equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standard)	Reported Device Performance (Peri-Prosthetic Cabling System)
Tensile Strength: Requirements of ASTM F2180 (Specific values not detailed in the text, but implies a minimum threshold for cable and crimp tensile properties).	"Tensile testing demonstrates that the Peri-Prosthetic Cabling System meets or exceeds the requirements of ASTM F2180." (This indicates successful compliance with the standard for tensile properties, which typically includes ultimate tensile strength, yield strength, and elongation at break).
Crimp Pull-Out Strength: Minimum requirements for pull-out strength (Specific values not detailed, but implies a minimum force required to separate the cable from the crimp).	"The crimp pull-out testing demonstrates that both the Peri-Prosthetic Cabling System and the predicate device meet the minimum requirements for pull out strength." (This shows the new device performs at least as well as the predicate and meets established safety/efficacy thresholds for crimp integrity).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact sample size used for the tensile and crimp pull-out testing. It only states "pre-clinical data including tensile and crimp pull-out testing."
Data Provenance: The data is described as "pre-clinical data." This typically implies laboratory testing conducted under controlled conditions. The country of origin of the data is not explicitly mentioned, but the submitting company is Biomet Trauma, located in Warsaw, IN, USA, so it's likely the testing was conducted in the USA or by a US-affiliated entity. The data is prospective in the sense that it was generated specifically for this submission to demonstrate substantial equivalence.

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 this submission. The "Peri-Prosthetic Cabling System" is a mechanical medical device, not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The performance is assessed through objective, quantifiable physical tests (tensile and pull-out strength) against established ASTM standards and internal minimum requirements.

4. Adjudication method for the test set

This information is not applicable. As discussed above, the performance is determined by objective physical measurements, not by human interpretation or adjudication.

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. This is a submission for a mechanical medical device, not an AI-driven diagnostic tool. Therefore, MRMC studies are not relevant.

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

This information is not applicable. This submission is for a mechanical medical device, not an algorithm or software device.

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

The "ground truth" for this device's performance is established by objective physical measurements (tensile forces, pull-out forces) compared against published industry standards (ASTM F2180) and internal minimum requirements. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing performance of this type of device. The ground truth is the scientific and engineering validation of its material properties and mechanical integrity.

8. The sample size for the training set

This information is not applicable. This is a mechanical device, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth to be established for it.

Summary

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K133354

Section 5 — 510(k) Summary

JAN 2 7 2014

Submitted by:	Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6391Fax: (305) 269-6400
Contact Person:	Julie Largent, Regulatory Affairs Specialist
Date Prepared:	October 25, 2013
Proprietary Name:	Peri-Prosthetic Cabling System
Common Name:	Cerclage Cable System
Classification Name:	Bone fixation cerclage (21 CFR § 888.3010)
Product Code:	JDQ
Predicate Devices:	The Peri-Prosthetic Cabling System is substantially equivalent tocurrently marketed Cable Plate System (K982545).
Device Description:	The new Peri-Prosthetic Cabling system consists of cables, crimp lugs(cable sleeves) and associated instrumentation. The cables andcrimp lugs are made of cobalt chromium alloy. All cables have a 7x7strand construction, with the overall cable having a 1.8mmdiameter.
Indications for Use:	The system.is intended for use in femur and tibia fractures,prophylactic banding, trochanteric reattachment, olecranonfractures, patella fractures, ankle fractures, fixation of spiralfractures in conjunction with intramedullary nailing and screwingtechniques, sternum fixation after open chest surgery andstabilization of cortical onlay strut grafts.
TechnologicalCharacteristics:	The technological characteristics of the Peri-Prosthetic CablingSystem are similar to the predicate device including design,dimensions and material. The minor technological differencesinclude cable diameter and a spike incorporated on the Peri-Prosthetic Cabling System crimp lug for bone purchase. The

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K133354

predicate device offers the cables in two diameters, while the Peri-Prosthetic Cabling System offers the cable in one diameter. The cable diameter of the Peri-Prosthetic Cabling System is within the range of the cable diameters of the predicate device.

Summary of Substantial Equivalence:

The Peri-Prosthetic Cabling System is substantially equivalent to the currently marketed device as demonstrated with pre-clinical data including tensile and crimp pull-out testing. Tensile testing demonstrates that the Peri-Prosthetic Cabling System meets or exceeds the requirements of ASTM F2180. The crimp pull-out testing demonstrates that both the Peri-Prosthetic Cabling System and the predicate device meet the minimum requirements for pull out strength. No new issues of safety or efficacy have been raised.

Peri-Prosthetic Cabling System - Traditional 510(k) Biomet Trauma

Page 47 of 97

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

January 27, 2014

Biomet, Incorporated Ms. Julie Largent Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K133354

Trade/Device Name: Peri-Prosthetic Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: December 20, 2013 Received: December 30, 2013

Dear Ms. Largent:

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 or any is 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

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Page 2 - Ms. Julie Largent

forth in the quality systems (OS) 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vincent Devlin -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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Section 4 - Indications for Use Statement

K133354 510(k) Number:

Peri-Prosthetic Cabling System Device Name:

Indications For Use:

× Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ElizabethFrank -S

Division of Orthopedic Devices

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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.