销售价格: | ¥ N/A |
商品编号: | AI-0134-0395 |
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 |
LAMA™
Automated Assessment of Long Leg Radiographs
Problems
Currently, pre-and post-total knee arthroplasty (TKA) lower limb alignment is assessed manually or with the aid of interactive software applications, resulting in high intra- and inter-reader variability, poor reproducibility and calibration errors.
Solutions
Fully-automated measurements aid users in quantifying limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs.
LAMA™ is here to support you!
Accurate & Precise
Deep learning technology enables automated accurate and precise measurement of knee alignment within ≤1° and leg-length discrepancy within ≤ 2mm [1]
Fast
Reading and reporting time of lower limb deformities radiographs can be reduced from 3 minutes to <1 minute (more than 3x faster) resulting in more time for patient care [2]
Implant Support
IB Lab LAMA™ now supports radiographs with total hip and total knee implants, providing 13 standardized measurements for both pre- and post-surgery radiographs [3]
Product description
LAMA™ uses deep learning technology to provide precise fully-automated geometric length and angle measurements of the lower limb on full leg X-ray images. The outputs aid healthcare professionals who are interested in the analysis of leg-length discrepancy and knee alignment in adult patients with suspected or present deformities of the lower extremities.
The user does not interact directly with IB Lab LAMA™ except to accept or reject the generated report findings via cleared third party medical viewers. The measurements are compared to fixed predetermined norm-ranges, based on standard state of the art clinical practices hard-coded into the software. Outputs are summarised in reports that can be viewed on any cleared medical DICOM viewer.
Findings
IB Lab LAMA™ provides the following measurements:
mechanical axis deviation
● full leg length
● femur length
● tibia length
● leg length discrepancy
● hip knee ankle angle
● anatomical tibiofemoral angle
● anatomical mechanical angle
● joint-line convergence angle
● mechanical lateral proximal femoral angle
● mechanical lateral distal femoral angle
● mechanical medial proximal tibia angle
● mechanical lateral distal tibia angle
Intended use
IB Lab LAMA™ is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA™ is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
References
[1] Clinical Study affiliated with University of Texas Southwestern Medical Center (UTSW) (K223646), 2023
[2] Simon, S., Schwarz, G.M., Aichmair, A. et al. Fully automated deep learning for knee alignment assessment in lower extremity radiographs: a cross-sectional diagnostic study. Skeletal Radiology (2021).
[3] Schwarz et al. Artificial intelligence enables reliable and standardized measurements of implant alignment in long leg radiographs with total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc. (KSSTA) 2022 doi: 10.1007/s00167-022-07037-9
[4] IB Lab US Market Survey 2020
G. McDaniel, K.L. Mitchell, C. Charles, V.B. Kraus: A comparison of five approaches to measurement of anatomic knee alignment from radiographs, November 16, 2009.
James M Hartford, Michael J Bellino: The learning curve for the direct anterior approach for total hip arthroplasty: a single surgeon’s first 500 cases, September 19, 2017.
World Health Organization: Increasing complexity of medical technology and consequences for training and outcome of care, August 2010.
IB Lab LAMA Clinical Validation study
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