The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

Device Description

The Thorecon Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Pioneer Sternal Cable of similar material.

The Thorecon Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum are manufactured from 420 or Custom 470 stainless steel.

Thorecon Fixation System devices are all single-use. The plates, complete with the necessary screws and instruments (screw driver and tensioner/cutter) required for completion of the surgery are provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.

AI/ML Overview

Here is an analysis of the acceptance criteria and supporting study for the Thorecon™ Fixation System, based on the provided text:

Preamble: The provided document is a 510(k) summary for a medical device (Thorecon™ Fixation System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "study" referenced in the context of this document primarily refers to non-clinical testing performed to show that the new device performs at least as safely and effectively as existing, legally marketed devices. It is not an effectiveness study in the typical sense of a clinical trial demonstrating a new treatment's efficacy.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary of Study Results)
Mechanical Performance	Passed Acceptance Criteria Established by Predicate Devices or Test Standards. Specific tests included: - Screw Push-Out of Plate Force Test - Bone Screw Pull-Out Test per ASTM F543 - Static Tension Testing - Dynamic Tension Testing
Packaging, Sterility & Shelf Life	Validation completed per standards: - ISO 11607 (Packaging) - ASTM D4169 (Shipping Containers) - ISO 11137-2 (Sterilization Dose) - ASTM F1980 (Accelerated Aging) - ISO 17665-1 (Moist Heat Sterilization)
Biocompatibility	Evaluation completed per ISO 10993 (Parts 1, 5, 10, and 11).
Pyrogenicity	Evaluated using Limulus amebocyte lysate (LAL) assay, ensuring endotoxin level meets the requirement of maximum endotoxin limit for implantable medical devices [20 EU per device].

Additional Information on the "Study" (Non-Clinical Testing)

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify numerical sample sizes for the individual mechanical, packaging, sterility, shelf life, biocompatibility, or pyrogenicity tests. It only states that these tests were performed and "passed acceptance criteria."
- The data provenance is internal, originating from testing conducted by or for A&E Medical Corporation to support their 510(k) submission. No specific country of origin for the data is mentioned, but the company is based in the USA. The tests are non-clinical (laboratory/bench) studies, not patient data (retrospective or prospective).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" and "experts" are terms typically used in studies involving subjective assessments (e.g., image interpretation, clinical diagnosis) where human judgment needs to be standardized or measured against a gold standard. For engineering and materials testing (mechanical performance, sterility, etc.), the "ground truth" is defined by established scientific principles, validated testing methodologies, and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective observations.
Adjudication Method for the Test Set:
- This is not applicable as the "test set" consists of non-clinical, objective measurements against pre-defined performance standards or predicate device performance, not subjective appraisals requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) interpreting medical images or clinical data, often with and without AI assistance, to assess diagnostic performance. The Thorecon™ Fixation System is a surgical implant; its performance is evaluated through biomechanical and materials testing, not through diagnostic interpretation.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- This question is not applicable as the Thorecon™ Fixation System is a physical medical device (surgical implant), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
The Type of Ground Truth Used:
- The "ground truth" for the non-clinical tests mentioned (mechanical, packaging, sterility, biocompatibility, pyrogenicity) is based on established industry standards (e.g., ASTM, ISO), regulatory requirements (e.g., FDA guidelines), and performance data from predicate devices. For example, for mechanical tests, the ground truth is a specific force or displacement value that the device must withstand or perform to a certain degree. For pyrogenicity, it's a defined endotoxin limit. For biocompatibility, it's compliance with established biological safety profiles.
The Sample Size for the Training Set:
- This question is not applicable. "Training set" refers to data used to train machine learning models. The Thorecon™ Fixation System is a physical medical device, not an AI software, and therefore does not have a "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not machine learning.
How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 7.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

February 12, 2018

A&E Medical Corporation % Sarah Pleaugh Regulatory Affairs Specialist RTI Surgical Inc. 375 River Park Circle Marquette, Michigan 49855

Re: K173579

Trade/Device Name: Thorecon™ Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC, GAQ Dated: January 22, 2018 Received: January 24, 2018

Dear Sarah 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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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Indications for Use

510(k) Number (if known)

K173579

Device Name Thorecon Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 A&E Medical. The logo consists of a black oval shape on the left side, with a white "A&E" symbol inside. To the right of the oval is the word "MEDICAL" in a simple, sans-serif font. A small registered trademark symbol is located to the right of the "L" in "MEDICAL".

510(k) Summary

Prepared on: February 12, 2018

510(k) Owner/Manufacturer:	A&E Medical Corporation5206 Asbury Road, PO Box 758Farmingdale, NJ 07727 USA
ContactPerson/Consultant:	Sarah Pleaugh, RACSr. Specialist, Regulatory AffairsRTI Surgical, Inc.Telephone: 1(906)226-9909 x 5861Fax: (386) 418-1627Email: spleaugh@rtix.com
Trade name:	Thorecon™ Fixation System
Commonname:	Sternal Fixation System
Classification:	Class II;21 CFR 888.3010 (JDQ, Cerclage, Fixation)21 CFR 888.3030 (HRS, Plate, Fixation, Bone)21 CFR 888.3040 (HWC, Screw, Fixation, Bone)21 CFR 878.4495 (GAQ, Suture, Nonabsorbable, Steel,Monofilament and multifilament, Sterile)
Panel:	Panel Code 87
Predicates:	K161876 Tritium Sternal Cable Plate SystemK931271 Ethi-pack Surgical Stainless Steel SutureK151019 SternaLock 360 Sternal Closure SystemK150581 Tritium Sternal Cable Plate SystemK111908 Biomet Microfixation Sternal Closure SystemK974016 Cerclage Cable with Hex Button (REFERENCE)K935481 Songer Cable System, Modification (REFERENCE)
Description:	The Thorecon Fixation System may be implanted via an open orminimally invasive approach. Where additional stability is desired,devices can be used with traditional monofilament wire or PioneerSternal Cable of similar material.The Thorecon Fixation System includes plates (some with integratedcable subassemblies) manufactured from 316L stainless steel(ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainlesssteel (ASTM F1314). Non-implantable needles, used to guide thecable around the sternum are manufactured from 420 or Custom 470stainless steel.Thorecon Fixation System devices are all single-use. The plates,complete with the necessary screws and instruments (screw driverand tensioner/cutter) required for completion of the surgery are
Indications for Use:	Summary of Technological Characteristics:	Discussion of Supporting Clinical Evidence and Non-Clinical Testing:
The Thorecon Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.	The subject devices were found to have similar technological characteristics as the predicate devices. Similarities to the predicate device include: Same intended use/ indications for use and contraindications Similar materials (metallic, stainless steel) Similar principles of operation and fundamental technology (plates, pre-assembled cerclage(s) and/or screws for fracture fixation) Similar instrumentation (e.g. screw driver, cable tensioner, cutters) Same general surgical technique method (sizing, cable insertion, approximation, tensioning, screw placement, final locking, removal of excess cerclage, closure; emergent re-entry available if necessary) Same sterility (gamma irradiation) and packaging (double sterile barrier) Same bacterial endotoxin evaluation and limit (20 EU/device) Similar / substantially equivalent mechanical performance There are minor differences in the design of the device and subject package configurations. However, the non-clinical testing completed supports that these differences do not raise different questions of safety or effectiveness.	No clinical evidence was provided in this submission.The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by predicate devices or test standards.Mechanical Performance Screw Push-Out of Plate Force Test
provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.
	Bone Screw Pull-Out Test per ASTM F543 Static Tension Testing Dynamic Tension Testing
	Packaging, Sterility and Shelf Life Validations completed per: ISO 11607 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ISO 17665-1 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
	Biocompatibility Evaluation per: ISO 10993 Biological evaluation of medical devices – Parts 1, 5, 10, and 11
	Pyrogenicity EvaluationPyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay. The device was tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
Conclusion:	The supporting evidence in this submission concludes the subject Thorecon Fixation System is substantially equivalent to the predicate devices. There are no new risks to safety or effectiveness raised

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Image /page/4/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black circle with a white design inside, followed by the text "MEDICAL" in black. The design inside the circle appears to be two intertwined letters, possibly "A" and "E", creating a unique and recognizable symbol for the company.

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Image /page/5/Picture/1 description: The image shows the logo for "A&E MEDICAL". The logo consists of a black circle with a white "A&E" symbol inside, followed by the word "MEDICAL" in black, sans-serif font. A small "®" symbol is present to the right of the word "MEDICAL".

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.