The ASTM is a global organization of volunteering experts responsible for more than 12,000 standards. In 2010, the subcommittee on Computer Assisted Orthopaedic Surgical Systems (F04-38) has released a first version of its standard F2554 on tracker accuracy assessment in computer-assisted surgery. By providing a thorough and realistic assessment of the accuracy of a surgical tracking system, this standard aims at improving surgical outcomes and ultimately serving the patient. It is no surprise then that this standard has aroused a strong interest from industry leaders but also regulatory bodies such as the FDA.
Since its creation more than 15 years ago, accuracy and trueness are part of the DNA of Atracsys LLC and its development teams. In fact, two of its R&D engineers have joined the ASTM subcommittee F04-38 to bring their expertise and their passion for this field. In 2021, they raised the need for a thorough revision of the standard F2554 and took leadership in the working group tasked with this revision. Months later, a much improved version of the standard, F2554-22, has been balloted and unanimously accepted by the ASTM at the committee and subcommittee level.
By the end of 2022, the revised version of the standard will be officially available on the ASTM website, but our R&D team has already created an open-source, cross-platform and cross-device software based on the new standard. This tool aims to assist the operator in performing the tests described in the standard and output all the required statistical analysis in a well-formated report. This software is open-source and cross-platform for a broader access, but thanks to the PlusToolkit framework, it is also compatible with many models of surgical tracking systems (see list of compatible devices at the end of download page).