It makes case-level output available to a PACS/workstation for worklist prioritization or triage. The reader study measured the AUC of the localization ROV response when using ClearRead CT relative to the unaided read. The company conducted a retrospective evaluation of 2,803 CT pulmonary angiogram (CTPA) exams of patients with suspected PE, from a single center. Multi-center retrospective anonymized study of adult patient CXR images was performed. Software validation and bench testing have been conducted. wrote. For each scan, 6 slices were selected for comparison. A secondary endpoint measure was Briefcase’s potential clinical benefit of worklist prioritization for true positive ICH cases. The AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists. A Passive notification for prioritization-only, parallel- workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D screening mammograms. The sensitivity and specificity of the HealthCXR was reported for two operating points, the first for equal sensitivity and specificity and the second operating point for a higher specificity. “The FDA has only just begun to develop procedures to evaluate the safety of AI-based medical imaging algorithms. A secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive PE cases. Aidoc conducted a retrospective, blinded, multicenter, multinational study with BriefCase software with the primary endpoint to evaluate the software’s performance in identifying non contrast CT head images containing ICH findings in 1198 cases form 3 clinical sites. Various laboratory testing was performed. Software testing was completed to ensure the new features operate according to defined requirements. The purpose of the testing was to have physicians use StoneChecker to analyze KUB CT scans, validate major functionalities provided by StoneChecker, and provide feedback on the clinical usability of StoneChecker. 2) 179 scans from 34 patients with ventriculostomy catheters 3) Laboratory testing of CT CoPilot segmentation reliability demonstrates equivalent test-retest performance as expert manually segmented subjects. The performance of the HealthMammo device has been validated in a performance study for triage of 2D FFDM screening mammogram cases. Sensitivity and specificity exceeded the 80 % performance goal. It was tested and validated with synthetic and phantom data. Results show that Case-level sensitivity, lesion-level sensitivity, FP rate in non-cancer cases, and specificity met design specifications. Performance testing included protocols demonstrating: Clinical data (including professionally labeled regions-of-interest, T2- weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and restricted signal map conspicuity). Non-clinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate devices, and that no new issues of safety and effectiveness were raised. 4. The paper highlights the various criteria the FDA believes will be used to determine just how much that medical products rely on AI, and therefore require FDA approval before being sold to customers. Viz CTP is a standalone software package that is comprised of several modules including DICOM receiving and sending modules, a study processor, image analysis algorithm, as well as software system components including a DICOM storage database and system health-monitoring. ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. Viz.ai conducted a retrospective study assess the standalone performance of the image analysis algorithm and notification functionally of Viz ICH. Viz ICH uses an artificial intelligence algorithm to analyze non-contrast CT images of the brain acquired in the acute setting, and sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. It is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics. The following design control measures were applied to the development of the Vitrea CT Lung. The U.S. Food and Drug Administration has approved a new artificial intelligence (AI) algorithm … 3. iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the RAPID ICH software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing ICH findings in 336 cases from US and OUS sites. The BriefCase time -to-notification for CSF was 3.9 minutes in contrast to the standard of care time-to-exam-open was 58.4 minutes. It flags those that are suggestive of the presence of at least one suspicious finding at the exam level. For example, an EF of 50 percent would mean the left ventricle pumps out half of the blood within it each contraction. The output also visualizes and quantifies white matter hyper intensity (WMH) candidates. The Zebra Pneumothorax device is a software tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Arterys Software v2.0 , Medis Imaging QMass. ProFound AI V2.1 has been verified and validated according to iCAD's design control processes. The first operating point showed a sensitivity of 96.74% and specificity of 93.17%. In April 2018 the company received FDA premarket approval (PMA) for its product IDx-DR, an AI diagnostic system that detects signs of diabetic retinopathy in retinal images. InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). assist the clinician in a cardiac evaluation. It can detect atrial fibrillation, a dangerous arrhythmia that can result in stroke if left untreated. The findings could be soft tissue lesions or calcifications. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies. NinesAI uses artificial intelligence algorithms to analyze head CT images for findings suggestive of a pre-specified emergent clinical condition. The technology leverages machine learning and image analysis with a large database of documented cases to help radiologists analyze MRIs. Identification of suspected findings is not for diagnostic use beyond notification. The purpose of the standalone study was to assess the standalone performance of PLTD V2 on a screening population. EchoMD AutoEF ejection fraction measurements were compared to the biplane method ejection fraction, and a root mean square deviation was calculated (8.29%). BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. For Brain Volumetry, the test set included 33 3DT1w MR images. Flow in Ascending Aorta (Partial) , Flow in Pulmonary Artery(Partial) , Pulmonary to Systemic Flow Ratio(Partial), Left Ventricle Volume(Partial), Cardiac Outputs(Partial). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired, transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on, images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in, order to provide automated estimation of left ventricular ejection fraction. The validation data was labeled by ground truth determined by three radiologists. Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data. For malignancy risk classification, bench testing was performed to ascertain the degree of concordance with trained interpreting physicians. Functional verification testing and development validation were conducted to verify that the design output met the design input requirements. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. Design verification testing which included confirming all labeling complies with 21CFR801 and all software requirements work as expected. CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. It was tested for compliance with the DICOM standard and passed the six DICOM specific test cases provided in section 4.4.4.2 of the Validation Test Report. DMDensity calculates percent breast density defined as the ratio of fibro-glandular tissue to total breast area estimates. A MRMC was performed. The difference from true locations in ClearRead Confirmn reads and unaided reads were not found to be statistically significant. Clinical validation was conducted in a MRMC study to validate that the device conformed to the defined user needs and intended uses. Vitrea CT Brain Perfusion software (K121213). Safety and performance of the device has been evaluated and verified in accordance with software specifications and applicable performance standards. All data sets were annotated and scored by readers independently with an additional majority vote consensus score. This system is designed to work alongside radiologists and help them make more accurate decisions, rather than to replace them. The device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the FDA guidance documents. The validation data set was truthed by three US Board-Certified Radiologists. Bench testing was performed to ascertain the degree of concordance with skilled physicians. There were 74 positive cases and 194 negative cases (images with iPE versus without iPE) included in the analysis. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS). Ground truth for shape and orientation was supplied by three MQSA certified radiologists. Icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. For brain tissues, the test set included 33 MR images which was carefully selected to include data from multiple vendors and a series of representative scan settings. A standalone study which evaluated the performance of PLTD without a radiologist was conducted with a sample of 655 Hologic DBT cases. Dataset included a total of 652 lesions, 314 benign, and 338 malignant. Ground truth for malignancy risk classification was determined by pathology or 1- year follow-up for cases that were not biopsied. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The experiments included data from 1399 subjects in total. Broncholab successfully passed verification testing. Aidoc conducted a retrospective, blinded, multicenter, multinational study with BriefCase software with the primary endpoint to evaluate the software’s performance in identifying non contrast CT head images containing ICH findings in 1198 cases form 3 clinical sites. This system was trained using a dataset of over four million images from 9,000 patients, and aims to assist cardiologists with rapid image analysis. The final standalone dataset was composed of 888 CXR images from 2 clinical sites from the US and 2 clinical sites from the UK. The Software automatically registers images and segments and analyzes ASPECTS Regions of lnterest (ROIs). syngo.CT Lung CAD(K143196) , syngo.PET&CT Oncology(K093621) , ClearRead Bone Suppression (SoftView)(K092363). The NinesAI device underwent performance testing to verify the efficacy and safety of the machine learning algorithms. Ground truth for the presence/absence of distal radius fracture is defined as the majority opinion of at least 2 of 3 clinicians participating. Sensitivity was 93.0% and specificity was 93.7%. In summary, performance validation data establish that KOALA is an effective image processing device that provides reliable measurements and accurate indicators for presence/absence of radiographic features relevant for the diagnosis and classification of osteoarthritis. The Quantib ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyper intensities. 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