(130 days)
The TL-HEX System is intended for limb lengthening by metaphyseal or epiphyseal 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. Within this range, indications 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. The System can also be used with other existing Orthofix external fixation components and screws (such as TrueLok or X Caliber).
Components of the system include:
• Full and 5/8 aluminum Rings
• 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
The provided text describes a medical device, the Orthofix TL-HEX True Lok Hexapod System (TL-HEX), and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or performance study for a diagnostic AI device would.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices under the 510(k) pathway. This means proving that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA). For the TL-HEX, this primarily involved mechanical and software testing to ensure the hardware components could withstand expected loads without failure and that the software performed as intended.
Therefore, the requested information based on a typical AI device performance study (e.g., sample size for test set, expert qualifications, MRMC study, ground truth establishment for training set) is not directly applicable or available in this document.
Here's an attempt to answer the questions based on the available information, noting where the information is absent due to the nature of the submission:
Acceptance Criteria and Study for Orthofix TL-HEX True Lok Hexapod System (TL-HEX)
The acceptance criteria for the Orthofix TL-HEX are primarily derived from the general safety and effectiveness requirements for external skeletal fixation devices and demonstrated through a comparison to predicate devices. The study performed was a series of mechanical and software tests to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Requirements for External Fixators & Software) | Reported Device Performance (from Performance Data section) |
|---|---|
| Mechanical Performance: Capable of withstanding expected loads without failure. | All testing met or exceeded the requirements established by test protocols and applicable standards. Hardware components are capable of withstanding expected loads without failure. |
| Software Performance: Software performs as intended. | Software verification and validation testing completed in conformance with FDA's guidance. Results indicate software performed as intended. |
| Safety Standard Compliance: Adherence to relevant ASTM standards for external skeletal fixation devices and metallic bone screws. | Compliance with: • ASTM F 1541-02 (2007) e1 "Standard Specification and Test Methods for External Skeletal Fixation Devices" • ASTM F1541-01 Annex 7 "Test Method for External Skeletal Fixator-Bone Constructs" • ASTM F543-07 Annex A2 "Test Method for Driving Torque of Metallic Bone Screws" |
| Software Quality: Demonstrated through IQ, OQ, PQ. | Software IQ, OQ, PQ testing was performed. |
| Risk Management: Hazards evaluated and controlled. | Potential hazards evaluated and controlled through a Risk Management Plan. |
| Substantial Equivalence: No new worst-case performance compared to predicates. | The subject device presents no new worst case for performance testing. (Found to be substantially equivalent to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described primarily involves mechanical and software validation, not a clinical "test set" in the sense of patient data. For mechanical testing, samples typically refer to units of the device components. For software testing, the "test set" would be a set of predefined inputs and scenarios used to verify software functionality, not patient data in the geographical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The evaluation focused on mechanical and software performance, not on establishing a "ground truth" based on expert interpretation of medical images or conditions for a diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple experts assess the same cases to derive a consensus ground truth. This type of methodology was not described for the mechanical and software testing performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is an external fixation system, including hardware and software for adjustment schedules. It is not an AI diagnostic tool primarily used for human reader assistance with image interpretation, so an MRMC study is not relevant to its stated function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions a "web-based software component that is designed to be used to assist the physician in creating a patient adjustment schedule." This implies a human-in-the-loop interaction rather than a standalone AI diagnosis. However, "software verification and validation testing was completed," indicating that the software's performance was evaluated independently from a clinical human-in-the-loop scenario to ensure its functionality and accuracy in generating adjustment schedules. The results stated "the software performed as intended."
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be established by the engineering specifications and expected performance under standardized test conditions (e.g., ability to withstand a certain load without deformation or fracture as defined by ASTM standards).
For the software, the "ground truth" for validation would involve comparing the software's calculated adjustment schedules against known correct calculations or engineering principles, as defined during the software design and development process. It's based on deterministic algorithms and mathematical models, rather than expert consensus, pathology, or outcomes data in the biological sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI system that relies on a "training set" of data for machine learning. Its software component generates adjustment schedules based on pre-programmed algorithms and patient-specific inputs, not on learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated above (not an AI device relying on a training set).
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2014
Orthofix Srl % Ms. Chervl Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408
Re: K141078 Trade/Device Name: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) 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: August 16, 2014 Received: August 18, 2014
Dear Ms. 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 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
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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/Resourcesfor You/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 vours.
Lori A. Wiggins -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): K141078 (pg 1/1)
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) Device Name:
Indications for Use:
The TL-HEX System is intended for limb lengthening by metaphyseal or epiphyseal distractions, fixation of open and closed fractures, treatment of nonunion or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. Within this range, indications 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
Prescription Use ________________________________________(21 CFR 801 Subpart (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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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 RicadonaQuality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| gianlucaricadona@orthofix.com |
Date Prepared April 17, 2014
| Trade Name | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) |
|---|---|
| Common Name | Multilateral Fixators and Accessories |
| Panel Code | Orthopaedics/87 |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT, OSN |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Smith & Nephew Inc, CircularSpatial Frame | K093047 | Smith and Nephew |
| True/Lok Monolateral/BilateralFixator | K941048 | Orthofix (originally submitted by AppliedOsteo Systems, Inc.) |
| Orthofix Modulsystem (XCaliber) | K955848 | Orthofix |
| 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. The System can also beused with other existing Orthofix external fixation components and screws(such as TrueLok or X Caliber). |
|---|---|
| Components of the system include:• Full and 5/8 aluminum Rings• Adjustable struts• Aluminum strut clips (number and direction)• Stainless steel instrumentation such as hex drivers, wrenches, andpliers• 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 |
|---|---|
| of non-union or pseudoarthrosis of long bones and correction of bony orsoft tissue defects or deformities. Within this range, indications include: | |
| • 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 Orthofix TL-HEXTrue Lok Hexapod System (TL-HEX) is substantially equivalent to thePredicates Smith & Nephew Inc, Circular Spatial Frame (K093047),True/Lok Monolateral/Bilateral Fixator (K941048), and OrthofixModulsystem (K955848). The TL-HEX System is substantially equivalentto the predicate devices in intended use, indications for use, technologicalcharacteristics, and labeling. |
| 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 are capableof withstanding expected loads without failure. Additionally, softwareverification and validation testing was completed in conformance withFDA's guidance document entitled "General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff." The results ofsoftware testing indicate that the software performed as intended. Theresults demonstrated that the Subject device presents no new worst casefor performance testing. The Subject device was therefore found to besubstantially equivalent to the Predicates. Clinical data was not neededto support the safety and effectiveness of the Subject Device.The following mechanical and software testing were performed:• ASTM F 1541-02 (2007) e1 "Standard Specification and TestMethods for External Skeletal Fixation Devices"• ASTM F1541-01 Annex 7 "Test Method for External Skeletal Fixator-Bone Constructs"• ASTM F543-07 Annex A2 "Test Method for Driving Torque ofMetallic Bone Screws"• Software IQ, OQ, PQ |
| Conclusion | Based on the indications for use, technological characteristics, materials,and comparison to predicate devices, the Subject Orthofix TL-HEX TrueLok Hexapod System (TL_HEX) has been shown to be substantially |
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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.