Beyond Precision: Expanding the Scope of Accuracy in Medical Innovations

Introduction

In the realm of medical technology, particularly in the development and application of Software as a Medical Device (SaMD), the accuracy of software outputs has traditionally been a focal point for developers, clinicians, and regulatory bodies alike.?

However, while accuracy remains a non-negotiable aspect of medical software development, it represents just one piece of a much larger puzzle. This article delves into the significance of Sim&Size, highlighting that the ultimate value of such technologies lies not merely in their precision but in the clinical benefits they deliver through the computation of biomarkers.

1. Accuracy: A Fundamental Requirement

Accuracy, the capability of Sim&Size to precisely compute outputs, is undeniably critical. Evaluated through various stages, including verification tests (>1000 tests), bench tests (>400 tests), silicone studies (>170 tests), and retrospective cases (>400 tests), accuracy ensures the software's reliability from its creation to post-marketing stage.?

These evaluations are conducted for all four Sim&Size’s modules and for various devices. The methodology and evaluated criteria are adjusted for each device depending on its characteristics.?

Across all cited above tests, Sim&Size achieved sub-millimetric accuracy in terms of deployed length. Moreover, all biomarkers computed by Sim&Size are evaluated in this process. These results justify its adherence to stringent FDA (510(k)) and CE (Regulation (EU) 2017/745) standards.

2. Accuracy is not sufficient

Nevertheless, while accuracy is indispensable, it is the direct and indirect clinical benefits derived from the software’s computation of biomarkers that stand as the most crucial measure of its efficacy.

In industries beyond healthcare, such as aviation, accuracy in instrument readings and system responses is vital. However, the ultimate measure of success in aviation is not just the precision of these systems but their contribution to overall flight safety, passenger comfort, and operational efficiency.?

Similarly, in medical devices, the focus should extend beyond the numerical accuracy of software outputs to the real-world clinical benefits these outputs facilitate.

3. Biomarkers: The Bridge to Clinical Benefits

A biomarker is a measurable indicator of some state or condition. In the context of simulation software like Sim&Size, biomarkers can include device deformation, length, apposition, and volume embolization ratio (VER) for coiling, among others. These indicators equip clinicians with additional information, enhancing the decision-making process. The selection and development of these biomarkers is based on an exhaustive assessment of the latest clinical practices and advances, and on a comprehensive and in-depth analysis of the literature.

Biomarkers serve as the core of Sim&Size’s computational capabilities, offering vital insights that extend beyond simple numerical accuracy. There is no debate that these biomarkers should be computed accurately. However, it is their demonstrated link to significant clinical benefits that truly defines the software’s added value.?

For instance, the precise simulation of flow diverters and intrasaccular devices with Sim&Size directly impacts treatment workflow, reducing operating time, exposure to radiation, number of devices deployed, additional maneuvers and nominal size of the implants. These benefits are demonstrated through clinical evidence.

Thus, the computation of relevant and useful biomarkers linked to clinical benefits exceeds traditional measures of accuracy, bridging the gap between technical precision and real-world clinical success.

Conclusion: Prioritizing Clinical Impact

In conclusion, while accuracy in a Software as a Medical Device (SaMD) like Sim&Size is essential and foundational, it is the clinical benefits derived from the computation of biomarkers that truly delineate its importance.?

Sim&Size's ability to calculate appropriate and useful biomarkers aims to improve the safety and efficacy of neurovascular interventions. But at Sim&Cure, we recognize the need to evaluate medical technologies in terms of clinical utility rather than accuracy alone.

As we advance, the focus must remain on the clinical benefits, ensuring that technological innovations in the medical field are aligned with the ultimate goal of improving patient care and treatment outcomes.

To sum up, exploring the accuracy of medical devices is essential, yet it should be a given for all medical devices, not a subject for debate. The focus of clinical studies and research needs to shift towards examining the clinical advantages offered by these devices, instead of solely concentrating on their precision.

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Sim&Size? is a medical device manufactured by Sim&Cure. According to the European Regulation, Sim&Size?software is a Class IIa medical device, it carries, under this regulation, the CE marking n°0459. Sim&Size? is intended for healthcare providers. The Sim&Size software is a medical device intended to provide a 3D view of the final deployment of implants. It uses an actual image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating deployment of implantable medical devices (IMD) in the artery to be treated and predicts the final position (length, diameter, form) and the extent of apposition of the implant. Sim&Size is not intended for diagnostic use or for recommending a specific treatment. Read the user manual carefully before use. Sim&Size? must not be used in the following cases : - on giant intracranial aneurysms involving poor reconstruction of the deployment zone - in presence of artifacts in the simulated Medical Device deployment zone - in the presence of Implantable Medical Device (IMD) that are potentially in contact with the simulated IMD in the deployment zone.

According to the US regulation Sim&Size? is a class II medical device FDA 510(k) cleared (K222664). Sim&Size? is intended for healthcare providers. Sim&Size? shall be used exclusively in accordance with the User Manual in force. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgment and analysis of the patient's condition. Sim&Size? enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. The use of Sim&Size? is contraindicated in the following cases: ? Sim&Size? must not be used on giant intracranial aneurysms involving poor reconstruction of the deployment zone. ? Sim&Size? must not be used in presence of artifacts in the region where the IMD is preoperationally planned to be deployed by the clinician. ? Sim&Size? must not be used in the presence of IMD that are potentially in contact with the computationally modelized IMD in the deployment zone.

Despite intensive verification and validation, the user must be aware that it is by nature impossible to test software in its entirety, and that defects may remain or occur as a result of its use under particular operating conditions. However, the use of Sim&Size does not lead to any additional risks to those known for neurovascular interventions. Use of the Sim&Size medical device is free from unacceptable risks when used in accordance with the intended purpose and indication for use specified by Sim&Cure . Individual and overall residual risks are acceptable and outweighed by the benefits to the patient. The benefit/risk ratio of the Sim&Size medical device is positive.