The ASTM F2789-10 Standard Guidelines for Mechanical and Functional Characterization of Core Devices, developed by the American Society for Testing and Materials (ASTM) , describes various forms of core replacement and core enlargement devices. It also outlines recommended test types for evaluating the performance of these devices.
The biocompatibility of materials used in a core replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their devices individually.
Although expulsion and endplate fractures are understood to represent documented clinical failures, this guideline does not specifically address them, although some factors related to expulsion are included.
This guide describes multiple test methods, however, the user is not required to use all of them. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential applications. Some tests may not be applicable to all device types. Additionally, some kernel devices may not be stable in all test configurations. However, this does not mean that the test methods described are not appropriate.
The science of core device design is still very new and involves technology that is changing faster than these guidelines can be modified. Therefore, the user should carefully consider the applicability of these guidelines to the user's particular device. These guidelines may not be appropriate for every device. For example, at the time of publication, these guidelines were designed to be partially or fully resorbable in the body and do not address core replacement and core augmentation devices. However, some of the tests recommended in these guidelines may be applicable to evaluate such devices. Mechanical failure of core devices has not been shown to be associated with adverse clinical outcomes. Therefore, this standard should be used with caution when evaluating proposed core devices.
This guideline is not intended to be a performance standard. It is the responsibility of the user of this guideline to characterize the safety and effectiveness of the core device being evaluated.
Core devices are often designed to augment the mechanical function of naturally degenerated core material or to replace tissue removed during a surgical procedure. This guide outlines methods for evaluating many different types of devices. Comparisons between devices should be made with caution and careful analysis, considering the effects of design and functional differences on test configurations and overall performance, and the possibility that mechanical failure may not correlate with clinical failure and, conversely, that mechanical success may not correlate with clinical success.
These tests are conducted in vitro to allow analysis of the mechanical performance of the core device under specific testing modalities. The applied loads may differ from the complex loading seen in vivo and therefore results from these tests may not directly predict in vivo performance.
These tests are used to measure the static and dynamic properties and performance of different implant designs. Mechanical tests are conducted in vitro using simplified loads and moments. Fatigue testing in a simulated body fluid or saline solution may have wear, aging, corrosion, or lubrication effects on the device and thus affect the relative performance of the devices being tested. Therefore, the test environment and its effect, whether a simulated body fluid, normal saline bath, or dry, is an important aspect of the test and should be reported accurately.
Dynamic test methods should be designed to answer many questions, including but not limited to: Does the device still perform as intended after the cycle? Does it maintain adequate performance characteristics? Has the device worn or deteriorated? If there is evidence of device wear or deterioration, it should be identified and quantified by generally available and reasonable methods. The user should distinguish between particles generated by the device and particles generated by the test pattern and fixtures, if technically possible.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, it also provides testing services defined in the "ASTM F2789-10 Standard Guide for Mechanical and Functional Characterization of Core Devices" standard with its trained and expert staff and advanced technological equipment.
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