Dataset Information

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

ABSTRACT: Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements.

SUBMITTER: Aisu N

PROVIDER: S-EPMC9931274 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Aisu Nao N Miyake Masahiro M Takeshita Kohei K Akiyama Masato M Kawasaki Ryo R Kashiwagi Kenji K Sakamoto Taiji T Oshika Tetsuro T Tsujikawa Akitaka A

PLOS digital health 20220118 1

Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using ...[more]

PMID: 36812514

Similar Datasets

Project description:BackgroundIn the future, more medical devices will be based on machine learning (ML) methods. In general, the consideration of risks is a crucial aspect for evaluating medical devices. Accordingly, risks and their associated costs should be taken into account when assessing the performance of ML-based medical devices. This paper addresses the following three research questions towards a risk-based evaluation with a focus on ML-based classification models.MethodsFirst, we analyzed how often risk-based metrics are currently utilized in the context of ML-based classification models. This was performed using a literature research based on a sample of recent scientific publications. Second, we introduce an approach for evaluating such models where expected risks and associated costs are integrated into the corresponding performance metrics. Additionally, we analyze the impact of different risk ratios on the resulting overall performance. Third, we elaborate how such risk-based approaches relate to regulatory requirements in the field of medical devices. A set of use case scenarios were utilized to demonstrate necessities and practical implications, in this regard.ResultsFirst, it was shown that currently most scientific publications do not include risk-based approaches for measuring performance. Second, it was demonstrated that risk-based considerations have a substantial impact on the outcome. The relative increase of the resulting overall risks can go up to 196% when the ratio between different types of risks (false negatives vs. false positives) changes by a factor of 10.0. Third, we elaborated that risk-based considerations need to be included into the assessment of ML-based medical devices, according to the relevant EU regulations and standards. In particular, this applies when a substantial impact on the clinical outcome / in terms of the risk-benefit relationship occurs.ConclusionIn summary, we demonstrated the necessity of a risk-based approach for the evaluation of medical devices which include ML-based classification methods. We showed that currently many scientific papers in this area do not include risk considerations. We developed basic steps towards a risk-based assessment of ML-based classifiers and elaborated consequences that could occur, when these steps are neglected. And, we demonstrated the consistency of our approach with current regulatory requirements in the EU.

Project description:Medical image analysis and computer-assisted intervention problems are increasingly being addressed with deep-learning-based solutions. Established deep-learning platforms are flexible but do not provide specific functionality for medical image analysis and adapting them for this domain of application requires substantial implementation effort. Consequently, there has been substantial duplication of effort and incompatible infrastructure developed across many research groups. This work presents the open-source NiftyNet platform for deep learning in medical imaging. The ambition of NiftyNet is to accelerate and simplify the development of these solutions, and to provide a common mechanism for disseminating research outputs for the community to use, adapt and build upon.The NiftyNet infrastructure provides a modular deep-learning pipeline for a range of medical imaging applications including segmentation, regression, image generation and representation learning applications. Components of the NiftyNet pipeline including data loading, data augmentation, network architectures, loss functions and evaluation metrics are tailored to, and take advantage of, the idiosyncracies of medical image analysis and computer-assisted intervention. NiftyNet is built on the TensorFlow framework and supports features such as TensorBoard visualization of 2D and 3D images and computational graphs by default.We present three illustrative medical image analysis applications built using NiftyNet infrastructure: (1) segmentation of multiple abdominal organs from computed tomography; (2) image regression to predict computed tomography attenuation maps from brain magnetic resonance images; and (3) generation of simulated ultrasound images for specified anatomical poses.The NiftyNet infrastructure enables researchers to rapidly develop and distribute deep learning solutions for segmentation, regression, image generation and representation learning applications, or extend the platform to new applications.

Project description:Glioblastoma Multiforme (GBM), classified as a grade IV glioma by the World Health Organization (WHO), is a prevalent and notably aggressive form of brain tumor derived from glial cells. It stands as one of the most severe forms of primary brain cancer in humans. The median survival time of GBM patients is only 12-15 months, making it the most lethal type of brain tumor. Every year, about 200,000 people worldwide succumb to this disease. GBM is also highly heterogeneous, meaning that its characteristics and behavior vary widely among different patients. This leads to different outcomes and survival times for each individual. Predicting the survival of GBM patients accurately can have multiple benefits. It can enable optimal and personalized treatment planning based on the patient's condition and prognosis. It can also support the patients and their families to cope with the possible outcomes and make informed decisions about their care and quality of life. Furthermore, it can assist the researchers and scientists to discover the most relevant biomarkers, features, and mechanisms of the disease and to design more effective and personalized therapies. Artificial intelligence methods, such as machine learning and deep learning, have been widely applied to survival prediction in various fields, such as breast cancer, lung cancer, gastric cancer, cervical cancer, liver cancer, prostate cancer, and covid 19. This systematic review summarizes the current state-of-the-art methods for predicting glioblastoma survival using different types of input data, such as clinical features, molecular markers, imaging features, radiomics features, omics data or a combination of them. Following PRISMA guidelines, we searched databases from 2015 to 2024, reviewing 107 articles meeting our criteria. We analyzed the data sources, methods, performance metrics and outcomes of the studies. We found that random forest was the most popular method, and a combination of radiomics and clinical data was the most common input data.

Project description:ImportanceThe marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelines set by the FDA to regulate AI- or ML-enabled medical devices, and discrepancies between FDA-approved indications for use and device marketing require articulation.ObjectiveTo explore any discrepancy between marketing and 510(k) clearance of AI- or ML-enabled medical devices.Evidence reviewThis systematic review was a manually conducted survey of 510(k) approval summaries and accompanying marketing materials of devices approved between November 2021 and March 2022, conducted between March and November 2022, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Analysis focused on the prevalence of discrepancies between marketing and certification material for AI/ML enabled medical devices.FindingsA total of 119 FDA 510(k) clearance summaries were analyzed in tandem with their respective marketing materials. The devices were taxonomized into 3 individual categories of adherent, contentious, and discrepant devices. A total of 15 devices (12.61%) were considered discrepant, 8 devices (6.72%) were considered contentious, and 96 devices (84.03%) were consistent between marketing and FDA 510(k) clearance summaries. Most devices were from the radiological approval committees (75 devices [82.35%]), with 62 of these devices (82.67%) adherent, 3 (4.00%) contentious, and 10 (13.33%) discrepant; followed by the cardiovascular device approval committee (23 devices [19.33%]), with 19 of these devices (82.61%) considered adherent, 2 contentious (8.70%) and 2 discrepant (8.70%). The difference between these 3 categories in cardiovascular and radiological devices was statistically significant (P < .001).Conclusions and relevanceIn this systematic review, low adherence rates within committees were observed most often in committees with few AI- or ML-enabled devices. and discrepancies between clearance documentation and marketing material were present in one-fifth of devices surveyed.

Dataset Information

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Publications

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets