The Tritium Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Description

The Tritium Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6Al 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3Al/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load-sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Tritium® Sternal Cable Plate System) and primarily focuses on establishing substantial equivalence to a predicate device.

Here's why I cannot fulfill your request:

No acceptance criteria or device performance data: The document states, "Engineering analysis was completed for the subject line extension product and demonstrated no new performance data was required for a determination of substantial equivalence." It also explicitly mentions, "No clinical performance data was required for a determination of substantial equivalence." This means there are no specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or reported device performance values available in this document.
No details on clinical studies: Since no clinical performance data was required, there are no details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
No ground truth establishment for a study: As no studies are described with performance outcomes, there's no information on how ground truth would have been established for a test or training set.
No training set information: The document discusses a device (implants, plates, cables, screws) used in surgical procedures, not an AI/ML algorithm that would require a training set.

The document mainly covers:

The device's intended use and indications.
Its components and materials.
Its classification and product codes.
Its substantial equivalence to a predicate device based on design, materials, and mechanical strength (without providing specific test results in this summary).

Therefore, I cannot extract the information requested as it is not present in the provided text.

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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.

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

September 9, 2016

Pioneer Surgical Technology, Inc. % Ms. Sarah Pleaugh Regulatory Affairs Specialist DBA RTI Surgical, Inc. 375 River Park Circle Marquette, Michigan 49855

Re: K161876

Trade/Device Name: Tritium® Sternal Cable Plate System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC Dated: August 18, 2016 Received: August 19, 2016

Dear Ms. Pleaugh:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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,

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) K161876

Device Name Tritium® Sternal Cable Plate System

Indications for Use (Describe)

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)

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Image /page/3/Picture/1 description: The image shows the logo for "rti surgical". The "rti" is in a blue square with rounded corners, and the letters are white with a small green dot above the "i". The word "surgical" is in gray, and there is a trademark symbol to the right of the word.

K161876

510(k) Summary As required per 21 CFR Section 807.92

Prepared:	September 8, 2016
510(k) Owner /Manufacturer:	Pioneer Surgical Technology, Inc.DBA RTI Surgical, Inc.375 River Park CircleMarquette, MI 49855 USATelephone: 906-226-9909Fax: 906-225-5868
Contact Person:	Sarah Pleaugh, RACRegulatory Affairs Specialist
Device trade/proprietary name:	Tritium® Sternal Cable Plate System
Common name:	Sternal Cable Plate System
Classificationregulation:	888.3010; Cerclage, Fixation, Metallic888.3030; Plate, Fixation, Bone, Non-Spinal, Metallic888.3040; Screw, Fixation, Bone, Non-Spinal, Metallic
Device class:	Class II
Product code:	JDQ, HRS, HWC
Review panel:	Panel Code 87; Orthopedic
Predicate device:	K150581 Tritium Sternal Cable Plate System
Description:	The Tritium Sternal Cable Plate System includes implants ofvarious sizes; plates and cable plugs comprised of commerciallypure titanium, Grade IV (ASTM F67), and cables and screwscomprised of Titanium 6Al 4V Alloy (ASTM F136). The systemalso includes needles comprised of Custom 470 stainless steel,420 stainless steel (ASTM F899, Custom 470 SST) and leadercomprised of Titanium 3Al/ 2.5V Alloy (ASTM F2146).The system is designed to enhance the stability and strength oftraditional sternal closure techniques. Utilizing a unique load-sharing concept, the device can be implanted to distribute lateralforce across the osteotomy. The system can be used withtraditional monofilament wire or Pioneer Sternal Cable. Thedevice system should be implanted using only the manual surgicalinstruments designed specifically for this system of implants,which may be implanted via an open or minimally invasiveapproach.

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Purpose of thissubmission:	The purpose of this submission is to obtain clearance ofmodifications (line extensions) to the predicate system (K150581).
Intended Use/Indications forUse:	The Tritium Sternal Cable Plate System is intended for use in thestabilization and fixation of fractures of the anterior chest wallincluding sternal fixation following sternotomy and sternalreconstructive surgical procedures.
Technologicalcharacteristics:	The subject system has the same or similar technologicalcharacteristics (overall design, material, principles of operation,and anatomical location of use) as the predicate. The subjectmodifications do not impact the technological characteristics ascompared to K150581.
Non-ClinicalPerformanceData:	Engineering analysis was completed for the subject line extensionproduct and demonstrated no new performance data was requiredfor a determination of substantial equivalence.Pyrogenicity will be evaluated using the Limulus amebocyte lysate(LAL) assay. The device will be tested to ensure the endotoxinlevel meets the requirements of maximum endotoxin limit forimplantable medical devices [20 EU per device].
ClinicalPerformanceData:	No clinical performance data was required for a determination ofsubstantial equivalence.
SubstantialEquivalence:	The subject line extension product is substantially equivalent topreviously cleared anterior chest wall fixation systems based oncomparison of intended use, materials, minimum number of screwholes per sternal half, screw hole geometry, cable/ needle/ leader/plug geometry design, technological characteristics, mechanicalstrength and performance. The modifications to the predicateK150581 system do not raise new issues of safety oreffectiveness.

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.