(55 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. 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 is a 510(k) Summary for the Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hardware Equivalence Test: The subject device hardware must be identical to the predicate device. | The subject device hardware is identical to the predicate device. |
| Risk Management Review: No new risks are introduced as a result of the modified indication. | It was determined through risk management that no new risks are introduced as a result of the modified indication. |
| Software Verification and Validation: Software performs as intended, conforming to FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." | Software verification and validation testing was completed in conformance with FDA's guidance. The results indicate that the software performs as intended. |
| Worst-Case Performance Equivalence: The subject device presents no new worst case for performance testing compared to the predicate. | The results demonstrated that the Subject device presents no new worst case for performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
As such, there is no mention of a clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The assessment relies on engineering and software validation data, and comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test set requiring ground truth established by experts was identified, this information is not applicable and not present in the document.
4. Adjudication Method for the Test Set
As there was no clinical test set, an adjudication method for ground truth is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device includes 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 document states, "Software verification and validation testing was completed... The results of software testing indicate that the software performs as intended." This suggests a standalone performance evaluation of the software components was conducted to ensure their functionality and accuracy in generating adjustment schedules. However, this is for the software component that assists a physician, not the entire physical system.
7. The Type of Ground Truth Used
For the hardware, the ground truth was the identity to the predicate device.
For the software, the ground truth was established by its demonstrated conformance to FDA's guidance for software validation and its intended performance. This implies that the software's outputs (e.g., patient adjustment schedules) were verified against expected or correct outputs, likely through internal validation standards and requirements.
8. The Sample Size for the Training Set
No training set is mentioned in the document because this K152171 pertains to demonstrating substantial equivalence for an updated version (V1.4) of an existing device (TL-HEX V1.3, K143125) and its software. The device is not learning or adaptive, so a traditional AI/ML training set is not applicable. The software's functionality is based on predefined algorithms for calculating adjustment schedules.
9. How the Ground Truth for the Training Set Was Established
As no training set was involved, this information is not applicable.
§ 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.