Computer aided detection software for colorectal polyps approved for marketing

腸息肉電子結(jié)腸內(nèi)窺鏡圖像輔助檢測(cè)軟件獲批上市

Recently, the "computer aided detection software for colorectal polyps" is approved for marketing by NMPA in China, which is an innovative product of Chengdu Wision Medical Device Co., LTD.

This product is provided in CD form and installed and used in stand-alone mode. It has 9 functional modules: acquisition card management, authorization management, drawing detection area, sound prompt, display option, displaying software information, monitoring running time, processing algorithm management and main program. The product is intended to be used in conjunction with designated models of video colonoscopes only in medical facilities to enable physicians to review the identified areas of suspect polyps presented in real time on the output stand-alone video images during colonoscopy in adults. The information is for reference only and physicians should make their own clinical judgment in combination with the patient's conditions.

The working principle of this product is to import video images at the video signal output port of endoscopic image processor, identify the areas of suspect polyps after software processing and algorithm analysis, and present it in a separate display. The product is the first medical device software in China that uses deep learning model to assist in the detection of polyps in endoscopic images. Small sample deep learning technology and local labeling technology are used to select and develop the algorithm model framework. The overall performance of the algorithm is not completely subject to the increase of training data and can achieve high performance, strong generalization and robustness in small samples.

This product is applied with electronic colonoscopes to help physicians identify the areas of suspect polyp during colonoscopy examination, which is conducive to earlier detection of precancerous lesions of rectal cancer, thereby reducing the incidence and mortality of rectal cancer.

NMPA will protects the public health by strengthening the post-marketing supervision to assure the quality, safety and effectiveness of this product

Attachment: Innovative Medical Devices Approved by NMPA (to be translated)

(8/3/2022)

近日，國家藥品監(jiān)督管理局經(jīng)審查，批準(zhǔn)了成都微識(shí)醫(yī)療設(shè)備有限公司生產(chǎn)的“腸息肉電子結(jié)腸內(nèi)窺鏡圖像輔助檢測(cè)軟件”創(chuàng)新產(chǎn)品注冊(cè)申請(qǐng)。

該產(chǎn)品以光盤形式提供，以單機(jī)方式安裝使用。具有采集卡管理、授權(quán)管理、繪制檢測(cè)區(qū)域、聲音提示、顯示選項(xiàng)、顯示軟件信息、監(jiān)測(cè)運(yùn)行時(shí)間、處理算法管理、主程序9大功能模塊。產(chǎn)品僅在醫(yī)療機(jī)構(gòu)內(nèi)與指定型號(hào)的電子結(jié)腸內(nèi)窺鏡配合使用，供執(zhí)業(yè)醫(yī)生在成人結(jié)腸內(nèi)窺鏡檢查時(shí)，對(duì)輸出的獨(dú)立視頻圖像進(jìn)行實(shí)時(shí)顯示疑似息肉區(qū)域。該信息僅供參考，醫(yī)生應(yīng)當(dāng)結(jié)合患者病情進(jìn)行臨床決策。

該產(chǎn)品工作原理為在內(nèi)窺鏡圖像處理器的視頻信號(hào)輸出端口導(dǎo)入視頻圖像，經(jīng)過軟件處理和算法分析后找出其中疑似息肉的位置，并在單獨(dú)的顯示器中顯示。該產(chǎn)品為國內(nèi)首個(gè)利用深度學(xué)習(xí)技術(shù)對(duì)內(nèi)窺鏡圖像中息肉進(jìn)行輔助檢測(cè)的醫(yī)療器械軟件，采用了小樣本深度學(xué)習(xí)技術(shù)和局部標(biāo)記技術(shù)進(jìn)行算法模型框架的選擇和開發(fā)，算法的整體性能不完全依賴訓(xùn)練數(shù)據(jù)的增加，能夠在較小樣本下實(shí)現(xiàn)高性能、強(qiáng)泛化性和魯棒性。

該產(chǎn)品與電子結(jié)腸內(nèi)窺鏡配合使用，可幫助醫(yī)生在進(jìn)行結(jié)腸鏡檢查時(shí)找出疑似息肉位置，有利于更早發(fā)現(xiàn)直腸癌的癌前病變，從而降低直腸癌發(fā)生率和死亡率。

藥品監(jiān)督管理部門將加強(qiáng)該產(chǎn)品上市后監(jiān)管，保護(hù)患者用械安全。

附件：國家藥監(jiān)局已批準(zhǔn)的創(chuàng)新醫(yī)療器械

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