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销售价格： ￥ N/A
商品编号： AI-0134-0393
软件语言： 英文
器械分类： II
生产厂家： ImageBiopsy Lab
公司网址： https://www.imagebiopsy.com/
认证信息： FDA
系统要求： Windows
交付方式： 下载安装
  • 软件概览
  • 推荐配置
  • 典型病例
  • 软件教程
  • 临床文献
  • 用户评价
  • 产品彩页

软件概览

KOALA™

Knee Osteoarthritis Labeling Assistant


Problems

Knee osteoarthritis (Knee-OA) is a debilitating bone and joint disease with the potential to necessitate joint replacement. It poses a significant health concern, as it carries a substantial lifetime risk of 45% [1]. This condition affects an enormous population, with over 200 million patients worldwide [2]. Furthermore, the high prevalence of knee X-rays in the European Union in 2020, totaling approximately 100 million [3], underscores the urgent need for effective strategies to manage and treat Knee-OA.

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Solutions

KOALA™ enhances physician agreement rates, offers precise measurements, and streamlines workflow for more efficient knee X-ray assessments.

Reliable measurements

87% sensitivity and 83% specificity discerning mild from moderate and severe knee OA based on KL score (>=2) [5]

Standardized reading

23% increase in physician’s agreement rate to gold standard [6]

Increased throughput

Workflow time savings range up to 25 days per year

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Product description

KOALA™ supports physicians in detecting signs of knee osteoarthritis based on standard joint parameters and OARSI criteria of standing radiographs of the knee.

Findings

Kellgren & Lawrence grade

Minimum joint space width

Joint space narrowing

Sclerosis

Osteophytosis


Intended use

IB Lab KOALA is a radiological fully-automated image processing software device intended to aid medical

professionals in the measurement of minimum joint space width; an assessment of the severity of sclerosis,joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the severity of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.

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推荐配置


典型病例


软件教程


临床文献

References

[1] Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021. PMID: 18759314; PMCID: PMC4516049.

[2] GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum in: Lancet. 2017 Jan 7;389(10064):e1. PMID: 27733282; PMCID: PMC5055577.

[3] Based on IB Lab Market Study

[4] OA PREVALENCE AND BURDEN

[5] KOALA fda 510(k) Summary 

[6] Nehrer, S., Ljuhar, R., Steindl, P., Simon, R., Maurer, D., Ljuhar, D., ... & Paixao, T. (2019). Automated Knee Osteoarthritis Assessment Increases Physicians’ Agreement Rate and Accuracy: Data from the Osteoarthritis Initiative. Cartilage, 1947603519888793. 



用户评价

What our customers say:

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产品彩页


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