Economic spectroscopic evaluation of Cervical Cancer

描述(由申请人提供)： 宫颈癌是全世界妇女中第二常见的癌症类型，也是发展中国家妇女癌症相关死亡的主要原因。及早发现和诊断可以挽救生命，减轻国家医疗体系的负担。我们已经建立了一个非侵入性的研究原型护理点设备来检测子宫颈的早期癌症状况。我们已经在一项多中心的全国性研究中测试了这个原型，该研究收集了600名女性的数据，用于训练我们的算法。通过与FDA的对话，我们现在已经有了一个关键的试验方案来验证我们的算法。在这项关键的研究中，我们将使用我们的设备的预产版。试生产设备将是一种成本更低、尺寸更小、便于携带、更坚固耐用的设备，其目的是与打算销售的设备完全相同，而不会产生进入生产阶段所需的模具成本。在此Fast Track应用程序的第一阶段，我们将解决构建此试生产设备的高风险方面，并得出概念性设计。在第二阶段，我们将最终确定这一设计(包括组件级别和系统集成)，并构建该设备的10个副本，以支持Pivotal试验。我们还将完成必要的系统测试，并确定设备间/设备内的可变性。我们将结束与我们的PMA提交必要的设计文件。

DESCRIPTION (provided by applicant): Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center national study accruing data from 600 women for training our algorithm. Through conversations with the FDA we now have in place a pivotal trial protocol for validating our algorithm. We will use a pre-production version of our device in this pivotal study. The pre-production device will be a cost and size reduced, portable, rugged and user-friendlier device and is intended to be identical to the device intended for sale without incurring the tooling costs necessary to enter the production phase. In Phase I of this fast track application we will address the high-risk aspects of building this pre-production device as well as arrive at a conceptual design. In Phase II we will finalize this design (both component level and systems integration) and build ten copies of the device to support the pivotal trial. We will also complete necessary systems tests and determine inter/intra device variability. We will conclude with the design documentation necessary for our PMA submission.