02. OpenSOTA

欢迎来到 OpenSOTA 项目！

OpenSOTA 项目致力于系统性地整理和收集各类医疗器械的临床背景（State-of-the-art, SOTA）信息。我们的目标是为医疗器械制造商、临床研究人员、法规事务专业人士以及其他相关方提供一个便捷、可靠的资源库，以支持他们满足欧盟医疗器械法规 (EU MDR) 对于临床评价计划 (CEP) 和临床评价报告 (CER) 的严格要求。

项目背景与价值

在 EU MDR 的框架下，准确、全面地描述特定医疗器械的 SOTA 是临床评价的核心组成部分。这包括对现有治疗方案、技术发展、临床实践指南、以及相关风险和受益的深入理解。传统上，SOTA 的撰写需要耗费大量时间进行文献检索、筛选、分析和总结。

OpenSOTA 项目的独特之处在于：

• 公开共享： 我们将经过系统性文献检索、分析和专家评估后汇总的 SOTA 内容公开发布，供用户免费参考和使用。目前已涵盖部分产品，并将持续扩展。
• AI赋能，提升效率与准确性： 我们采用先进的人工智能（AI）辅助工具进行文献检索、数据提取和分析，极大地提高了信息处理的效率和准确性，使得我们能够更快地完成高质量的 SOTA 内容。
• 满足合规需求： 提供的 SOTA 信息旨在帮助用户理解特定医疗器械领域的最新进展，为其 CEP 和 CER 的撰写提供坚实的基础，并能够直接应用于临床背景和安全有效性阈值的部分。
• 持续更新与扩展： 我们将不断努力，逐步覆盖更多医疗器械产品类型，并定期更新现有内容，以反映最新的临床证据和现有技术水平。

免费与增值服务

我们公开分享的 SOTA 内容是基于对公开医学指南、已发表文献的系统性检索和严谨分析后形成的总结性信息。这些内容可以帮助您快速了解特定领域的临床背景。

为了维持项目的可持续运营并提供更深层次的支持，我们同时提供增值服务。对于需要详细原始记录的用户，例如完整的文献检索策略、文献纳入/排除标准与记录、原始数据分析过程以及最终引用的参考文献列表等，可以联系我们获取付费支持。这些详细资料对于构建完整的、可追溯的临床评价文档至关重要。

我们的愿景

OpenSOTA 项目致力于成为医疗器械行业内领先的 SOTA 信息资源平台，通过结合专业知识与创新技术，助力行业提升临床评价的质量与效率，最终惠及患者安全与健康。

您可以随时免费浏览已发布的 SOTA 内容，我们期待您的反馈。如果您有特定的产品SOTA需求或合作意向，欢迎与我们联系。

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Welcome to the OpenSOTA Project!

The OpenSOTA project is dedicated to systematically compiling and collecting Clinical Background (State-of-the-art, SOTA) information for a wide range of medical devices. Our goal is to provide medical device manufacturers, clinical researchers, regulatory affairs professionals, and other stakeholders with a convenient and reliable resource hub to support their efforts in meeting the stringent requirements of the EU Medical Device Regulation (EU MDR) for Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).

Project Background and Value

Under the EU MDR framework, an accurate and comprehensive description of the SOTA for a specific medical device is a core component of the clinical evaluation. This involves a thorough understanding of existing treatment options, technological advancements, clinical practice guidelines, and associated risks and benefits. Traditionally, compiling SOTA information has been a time-consuming process involving extensive literature searches, screening, analysis, and summarization.

What makes the OpenSOTA project unique:

• Open Access: We publicly share summarized SOTA content that has been developed through systematic literature searches, analysis, and expert review, available for users to reference and utilize free of charge. We have already covered some products and will continue to expand our coverage.
• AI-Powered Efficiency and Accuracy: We leverage advanced Artificial Intelligence (AI) assistive tools for literature retrieval, data extraction, and preliminary analysis. This significantly enhances the efficiency and accuracy of information processing, allowing us to deliver high-quality SOTA content more rapidly.
• Compliance Support: The SOTA information provided is designed to help users understand the latest developments in specific medical device areas, offering a solid foundation for the preparation of their CEPs and CERs, and could be used for the sections of clinical background and safety & performance parameters.
• Continuous Updates and Expansion: We are committed to progressively covering more medical device product types and regularly updating existing content to reflect the latest clinical evidence and the state-fo-the-art.

Free and Value-Added Services

The SOTA content we share publicly consists of summarized information derived from systematic searches and rigorous analysis of public medical guidelines and published literature. This content can help you quickly grasp the clinical background of a specific field.

To ensure the sustainable operation of the project and provide deeper support, we also offer value-added services. For users requiring detailed original records, such as complete literature search strategies, literature inclusion/exclusion criteria and records, raw data analysis processes, and the final list of cited references, paid support is available upon request. These detailed materials are crucial for constructing comprehensive and traceable clinical evaluation documentation.

Our Vision

The OpenSOTA project aims to become a leading SOTA information resource platform within the medical device industry. By combining professional expertise with innovative technology, we strive to help the industry enhance the quality and efficiency of clinical evaluations, ultimately benefiting patient safety and health.

You can easily explore our published SOTA content, and we welcome your feedback. If you have specific product SOTA needs or collaboration inquiries, please do not hesitate to contact us.