(115 days)
The Thorecon Rigid Fixation 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. The system is intended for use in patients with normal and/or poor bone quality.
The Thorecon Rigid 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 Sternal Cable of similar material. The Thorecon Rigid 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 devices are all single-use. The plates, complete with the necessary screws and instruments (torque driver and tensioner/cutter) required for completion of the surgery, are provided sterile in a disposable 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.
The provided text is a 510(k) Premarket Notification for the Thorecon™ Rigid Fixation System. It describes a medical device related to bone fixation, specifically for the sternum. The document focuses on regulatory approval and substantial equivalence to a predicate device, supported by non-clinical (mechanical and MR safety) testing.
Therefore, the information requested about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document concerns a physical medical device (implants, screws, etc.) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD) product.
The document states:
- Purpose of Submission: To obtain clearance of modifications to the Thorecon Rigid Fixation System, including the addition of MR Conditional Safety Labeling.
- Discussion of Supporting Non-Clinical Testing: "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 the predicate device where applicable."
- Mechanical Performance (Worst-Case Construct Assessment, Assessment of previously completed testing, Cerclage Dynamic Tension Testing)
- MR Safety Evaluation following standards (ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a, ASTM F2119-07)
Since the request is specifically about a study that proves a device meets acceptance criteria, and the provided text is about a physical medical device (Thorecon™ Rigid Fixation System) rather than a software or AI device, it's important to clarify that the "device" in question here is the implantable hardware.
Here's an interpretation of the acceptance criteria and the study based on the provided document, in the context of a physical medical device, while acknowledging that the original prompt's questions are generally geared towards AI/SaMD.
Acceptance Criteria and Device Performance (for a Physical Medical Device)
The document does not explicitly list quantitative acceptance criteria in a table format with reported performance for individual tests. Instead, it states that all identified nonclinical tests "passed acceptance criteria established by the predicate device where applicable." This indicates a qualitative statement of compliance rather than specific numerical values.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, this exact table cannot be constructed with specific numerical values as they are not provided.
| Acceptance Criterion (Type of Test) | Basis for Acceptance | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate device (K173579 Thorecon Fixation System). Passed acceptance criteria established by predicate. | Passed |
| Worst-Case Construct Assessment | Acceptable performance as compared to predicate. | Passed |
| Cerclage Dynamic Tension Testing | Acceptable performance as compared to predicate. | Passed |
| MR Safety Evaluation | Compliance with ASTM standards and FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014. | Device determined to be MR Conditional based on results of testing. |
| Magnetically Induced Displacement Force (ASTM F2052-15) | Met standard | Passed |
| Magnetically Induced Torque (ASTM F2213-17) | Met standard | Passed |
| Radio Frequency Induced Heating (ASTM F2182-11a) | Met standard | Passed |
| MR Image Artifacts (ASTM F2119-07) | Met standard | Passed |
2. Sample Size Used for the Test Set and the Data Provenance
For a physical device's mechanical and MR safety testing:
- Sample Size: Not explicitly stated as "sample size" in the context of human data. For mechanical and MR safety testing of physical devices, samples would refer to the number of device units tested. This specific number is not provided in the summary.
- Data Provenance: This is not applicable in the context of human data or geographical origin for mechanical and MR safety testing of a physical device. These tests are laboratory-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for mechanical and MR safety testing of a physical medical device is established by physical measurements and compliance with engineering standards, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. This applies to subjective human interpretations for ground truth, not objective physical testing.
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
Not applicable. This is for AI-assisted image interpretation or similar cognitive tasks, not for a physical implantable device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI algorithms, not a physical implantable device.
7. The Type of Ground Truth Used
- For Mechanical Performance: Engineering specifications, material properties, and comparative performance against the predicate device.
- For MR Safety Evaluation: Compliance with established ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07) and FDA guidance for MR conditional labeling.
8. The Sample Size for the Training Set
Not applicable. This terminology refers to machine learning models. For a physical device, there isn't a "training set" in the AI sense. Design and manufacturing processes are iteratively refined based on engineering principles and test results.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is for AI models. Principles of engineering and materials science guide the design and manufacturing of the device.
Summary in relation to the document:
The provided document, a 510(k) Premarket Notification, is for a physical medical device (Thorecon™ Rigid Fixation System) which aids in sternal fixation. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for mechanical performance and MR compatibility. The document states that these tests were conducted and "passed acceptance criteria established by the predicate device where applicable" and complied with relevant ASTM standards and FDA guidance for MR safety, leading to the "MR Conditional" designation.
The questions in the prompt are largely tailored for Artificial Intelligence (AI) or Software as a Medical Device (SaMD) products, which typically involve performance evaluation based on human-interpreted data, often medical images. The nature of the Thorecon™ Rigid Fixation System and the testing described in this 510(k) summary (mechanical and MR safety) does not involve AI or human data interpretation studies of the kind implied by the questions.
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A&E Medical Corporation % Sarah Pleaugh Regulatory Affairs Sr. Specialist RTI Surgical, Inc 375 River Park Circle Marquette, Michigan 49855
October 12, 2018
Re: K181607
Trade/Device Name: Thorecon™ Rigid Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC, GAQ Dated: June 15, 2018 Received: June 19, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Daniel S. Ramsey -S 2018.10.12 15:35:25 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Thorecon Rigid Fixation System
Indications for Use (Describe)
The Thorecon Rigid Fixation 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. The system is intended for use in patients with normal and/or poor bone quality.
| 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 a company called "A&E MEDICAL". The logo consists of a black circle with two white intertwined shapes resembling the letters "A" and "E" on the left side. To the right of the circle, the word "MEDICAL" is written in a simple, sans-serif font, with a small registered trademark symbol next to the "L".
510(k) Summary
Prepared on: June 15, 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™ Rigid 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 |
| Predicate: | K173579 Thorecon Fixation System |
| Description: | The Thorecon Rigid Fixation System may be implanted via an openor minimally invasive approach. Where additional stability is desired,devices can be used with traditional monofilament wire or SternalCable of similar material. |
| The Thorecon Rigid Fixation System includes plates (some withintegrated cable subassemblies) manufactured from 316L stainlesssteel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mnstainless steel (ASTM F1314). Non-implantable needles, used toguide the cable around the sternum, are manufactured from 420 orCustom 470 stainless steel. | |
| Thorecon devices are all single-use. The plates, complete with thenecessary screws and instruments (torque driver andtensioner/cutter) required for completion of the surgery, are providedsterile in a disposable kit. Sterile instruments and screw multi-packsand a non-sterile cable/ plate cutter instrument are also available asreplacements and for use during emergent re-entry, if necessary.The devices should be implanted using only the manual surgicalinstruments designed specifically for the implants in the system. | |
| Indications for Use: | The Thorecon Rigid 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. |
| Purpose of Submission:Summary of Technological Characteristics: | To obtain clearance of modifications to the Thorecon Rigid Fixation System, including the addition of MR Conditional Safety Labeling.The subject devices have the same technological characteristics as the predicate K173579, including:intended use/ indications for use and contraindications materials (metallic, stainless steel) principles of operation and fundamental technology (plates, pre-assembled cerclage(s) and/or screws for fracture fixation) instrumentation (e.g. torque driver, cable tensioner, cutters) surgical technique method (sizing, cable insertion, approximation, tensioning, screw placement, final locking, removal of excess cerclage, closure; emergent re-entry available if necessary) sterility (gamma irradiation) and packaging (double sterile barrier) bacterial endotoxin evaluation and limit (20 EU/device) substantially equivalent mechanical performance The modifications in labeling and design are supported by non-clinical testing listed below. |
| Discussion of Supporting Non-Clinical Testing: | 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 the predicate device where applicable.Mechanical Performance Worst-Case Construct Assessment Assessment of previously completed testing Cerclage Dynamic Tension Testing MR Safety Evaluation following standards listed below: ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment" ASTM F2213-17, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment" |
| ASTM F2182-11a, “Standard Test Method for Measurement ofRadio Frequency Induced Heating Near Passive ImplantsDuring Magnetic Resonance Imaging” ASTM F2119-07 (Reapproved 2013), “Standard Test Methodfor Evaluation of MR Image Artifacts from Passive Implants” | |
| Conclusion: | The subject Thorecon Rigid Fixation System was shown to besubstantially equivalent to the predicate system. The devices aredetermined to be MR Conditional based on the results of testingcompleted according to FDA Guidance document "EstablishingSafety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment", December 11, 2014. |
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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 oval shape with the letters "A&E" in white inside the oval. To the right of the oval is the word "MEDICAL" in black, sans-serif font, with a registered trademark symbol next to it.
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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 oval shape with two white intertwined letters, "A" and "E", on the left side. To the right of the oval is the word "MEDICAL" in black, sans-serif font, with a small registered trademark symbol next to it.
§ 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.