(68 days)
The TL-HEX System is intended for limb lengthening by metaphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
Indications, both for adults and all pediatric subgroups except newborns, include:
- · Post-traumatic joint contracture which has resulted in loss of range of motion
- · Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- · Open and closed fracture fixation
- · Pseudoarthrosis of long bones
- · Limb lengthening by epiphyseal or metaphyseal distraction
- · Correction of bony or soft tissue deformities
- · Correction of bony or soft tissue defects
- · Joint arthrodesis
- · Infected fractures or non unions
The Subject device is a multilateral external fixation system. The System can also be used with a web-based software component that is designed to be used to assist the physician in creating a patient adjustment schedule that assists in adjusting the six struts.
Components of the System include:
Full, 5/8 and 3/8 aluminum Rings Double Row Footplates Adjustable struts Aluminum strut clips (number and direction) Stainless steel instrumentation such as hex drivers, wrenches, and pliers Implantable components such as half pins and wires Web-based software
This document (K170650) describes the Orthofix TrueLok Hexapod System (TL-HEX) V2.0, an external fixation system used for various orthopedic conditions. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific algorithm performance for an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device performance metrics, such as accuracy, sensitivity, specificity, and aspects of a clinical study for AI systems, is not present in this document.
The document primarily covers the mechanical and software validation of the device, focusing on its physical and computational aspects for planning, rather than AI-driven diagnostic or prognostic capabilities.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria or reported performance in the typical format for an AI/ML device (e.g., accuracy, sensitivity, specificity). Instead, it refers to:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance to withstand expected loads | All testing met or exceeded the requirements established by test protocols and applicable standards. Hardware components capable of withstanding expected loads without failure. |
| Software functionality as intended | Software verification and validation testing completed in conformance with FDA guidance. Results indicate updated software continues to perform as intended. |
| Compliance with ASTM F1541-02 "Standard Specification and Test Methods for External Skeletal Fixation Devices" | Testing was performed against this standard. |
| Software IQ, OQ, PQ (Installation, Operational, Performance Qualification) | These qualifications were completed. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device for bone fixation and correction, not an AI/ML diagnostic or prognostic system that processes patient data/images for analysis. Therefore, there is no "test set" in the context of patient data for AI model evaluation.
The "testing" mentioned refers to mechanical and software validation of the device's components and planning software. The sample sizes for these engineering tests (e.g., number of devices tested, number of software iterations tested) are not specified in this summary.
Data Provenance: Not applicable in the context of patient data for AI/ML. The device itself is manufactured by Orthofix Srl in Italy.
Retrospective or Prospective: Not applicable as it's not a study on patient data or clinical outcomes in the AI context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes validation of a mechanical and software system for surgical planning, not an AI/ML system requiring expert-established ground truth from medical images/data. The ground truth for the software's performance is its ability to accurately calculate adjustment schedules based on physician input, and for the mechanical components, it's their ability to withstand loads according to engineering standards.
4. Adjudication Method for the Test Set
Not applicable. As there's no "test set" of patient cases for AI evaluation, there's no need for an adjudication method by medical experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC study. The device is a physical fixation system along with planning software; it is not presented as an AI assistance tool for human readers in diagnostic tasks. Therefore, there's no discussion of human readers improving with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The "software component" mentioned assists the physician in creating an adjustment schedule. This implies a human-in-the-loop system where the physician uses the software as a tool. The document does not provide a standalone performance evaluation of an algorithm without human input, as this is not an AI diagnostic algorithm.
7. The Type of Ground Truth Used
For the mechanical components, the ground truth is established by engineering standards (e.g., ASTM F1541-02) and internal test protocols for resisting specified loads without failure.
For the software, the ground truth relates to its computational accuracy and functional correctness in generating adjustment schedules based on input data, validated through standard software verification and validation (V&V) procedures (IQ, OQ, PQ). It's not based on expert consensus from medical images or pathology.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a software application that calculates adjustments, not an AI/ML model that would require a "training set" of data to learn from. The software is likely based on deterministic algorithms and geometric principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, there is no ground truth established for it.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC P O Box 15729 Wilmington, North Carolina 28408
May 10, 2017
Re: K170650
Trade/Device Name: Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: April 7, 2017 Received: April 11, 2017
Dear Cheryl Wagoner:
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
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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.
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,
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)
к170650
Device Name
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Indications for Use (Describe)
The TL-HEX System is intended for limb lengthening by metaphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
Indications, both for adults and all pediatric subgroups except newborns, include:
- · Post-traumatic joint contracture which has resulted in loss of range of motion
- · Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- · Open and closed fracture fixation
- · Pseudoarthrosis of long bones
- · Limb lengthening by epiphyseal or metaphyseal distraction
- · Correction of bony or soft tissue deformities
- · Correction of bony or soft tissue defects
- · Joint arthrodesis
- · Infected fractures or non unions
| 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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Special 510(k) Premarket Notification Orthofix TrueLok Hexapod System (TL-HEX) V2.0
510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 | |
| 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca RicadonaSr. Quality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| GianlucaRicadona@orthofix.it |
Date Prepared March 1, 2017
| Trade Name | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 |
|---|---|
| Common Name | Multilateral Fixators and Accessories |
| Panel Code | 87/ Orthopaedic |
| ClassificationName | Single/multiple component metallic bone fixation appliances andaccessories |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT, OSN |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | K152171 | Orthofix Srl |
| Description | The Subject device is a multilateral external fixation system. The Systemcan also be used with a web-based software component that is designedto be used to assist the physician in creating a patient adjustmentschedule that assists in adjusting the six struts.Components of the System include:Full, 5/8 and 3/8 aluminum Rings Double Row Footplates Adjustable struts Aluminum strut clips (number and direction) Stainless steel instrumentation such as hex drivers, wrenches,and pliers Implantable components such as half pins and wires Web-based software |
|---|---|
| Indications andIntended Use | The TL-HEX System is intended for limb lengthening by metaphyseal orepiphyseal distractions, fixation of open and closed fractures, treatment ofnon-union or pseudoarthrosis of long bones and correction of bony or softtissue defects or deformities. Indications, both for adults and all pediatric |
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| subgroups except newborns, include but are not limited to: | |
|---|---|
| • Post-traumatic joint contracture which has resulted in loss of range ofmotion | |
| • Fractures and disease which generally may result in joint contracturesor loss of range of motion and fractures requiring distraction | |
| • Open and closed fracture fixation | |
| • Pseudoarthrosis of long bones | |
| • Limb lengthening by epiphyseal or metaphyseal distraction | |
| • Correction of bony or soft tissue deformities | |
| • Correction of bony or soft tissue defects | |
| • Joint arthrodesis | |
| • Infected fractures or non-unions | |
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Subject device issubstantially equivalent to the Predicate Orthofix TL-HEX True LokHexapod System (TL-HEX) V1.4 (K152171).The subject device is substantially equivalent to the predicate device inintended use, indications for use, site of application, patient population,condition of use, technological characteristics, materials, mechanicalperformances and implantable components.The Subject device includes additional hardware components, minorchanges to some existing ones and updated software version respect tothe predicate. |
| Performance Data | The potential hazards have been evaluated and controlled through a RiskManagement Plan.All testing met or exceeded the requirements, as established by the testprotocols and applicable standards. A review of the mechanical dataindicates that the hardware components of the Subject device continuesto be capable of withstanding expected loads without failure.Additionally, software verification and validation testing were completed,in conformance with FDA's guidance document entitled "GeneralPrinciples of Software Validation; Final Guidance for Industry and FDAStaff." The results indicate that the updated software continues toperform as intended.The Subject device was therefore found to be substantially equivalent tothe Predicate device.Clinical data was not needed to support the safety and effectiveness ofthe Subject Device.The following mechanical and software testing were performed:• ASTM F1541-02 "Standard Specification and Test Methods forExternal Skeletal Fixation Devices"• Software IQ, OQ, PQ |
| Conclusion | Based upon similarities in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances and implantable components. Orthofix TrueLok Hexapod System (TL-HEX) V2.0 has been shown to be substantially equivalent to the legally marketed predicate device, and to be safe and effective for its intended use. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.