The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study

2015 ◽  
Vol 81 (3) ◽  
pp. 207-214
Author(s):  
Femke Mulder ◽  
Dorine Piersma ◽  
Sebastiaan Veersema ◽  
Joris van der Post ◽  
Jan-Paul Roovers
Keyword(s):  
Medical Device ◽  
Validation Study ◽  
Clinical Validation

406 Clinical Validation of AI Scoring in Adult and Pediatric Clinical PSG Samples Compared to Prospective, Double-Blind Scoring Panel

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A161-A161
Author(s):  
Chris Fernandez ◽  
Sam Rusk ◽  
Nick Glattard ◽  
Yoav Nygate ◽  
Fred Turkington ◽  
...  
Keyword(s):  
Validation Study ◽  
Periodic Breathing ◽  
Sleep Stages ◽  
Clinical Validation ◽  
Double Blind ◽  
Adult Age ◽  
Public Data ◽  
Patient Reported ◽  
Funding Opportunities ◽  
Sensitivity Specificity

Abstract Introduction Despite an appreciable rise in sleep wellness and sleep medicine A.I. research publications, public data corpuses, institutional support, and health A.I. research funding opportunities, the availability of controlled-retrospective, hybrid-retrospective-prospective, and prospective-RCT quality clinical validation study evidence is limited with respect to their potential clinical impact. Furthermore, only a few practical examples of A.I. technologies are validated, in use today clinically, and widely adopted, to assist in sleep diagnoses and treatment. In this study, we contribute to this growing body of clinical A.I. validation evidence and experimental design methodologies with an interoperable A.I. scoring engine in Adult and Pediatric populations. Methods Stratified random sampling with proportionate allocation was applied to a database of N>10,000 retrospective diagnostic clinical polysomnography (PSG), selected by evidence grading standards, with controls applied for OSA severity, diagnoses; sleep, psychiatric, neurologic, neurodevelopmental, cardiac, pulmonary, metabolic disorders, medications; benzodiazepines, antidepressants, stimulants, opiates, sleep aids, demographic groups of interest; sex, adult age, pediatric age, BMI, weight, height, and patient-reported sleepiness, to establish representative N=100 Adult and N=100 Pediatric samples. Double Blinded scoring was prospectively collected for each sample by 3 experienced RPSGT certified sleep technologists randomized from a pool of 9 scorers. Sensitivity (PA), Specificity (NA), Accuracy (OA), Kappa (K), and 95% Bootstrap CI’s are presented for sleep stages, OSA/CSA, hypopnea 3%/4%, arousals, limb movements, Cheyenne-Stokes respiration, periodic breathing, atrial fibrillation, and other events, and normative, mild, moderate, and severe OSA categories for global-AHI and REM-AHI. Results for Sleep Staging and OSA Severity Diagnostic Accuracy are summarized. Results A.I. scoring performance meet but in most cases exceeded initial clinical validation study (N=72 Adults, 2017) PA, NA, OA, K point-estimates and confidence-interval results for the 26 event types and 8 AHI-categories evaluated. The Adult sample showed 87%/94% Sensitivity/Specificity across all stages (Wake/N1/N2/N3/REM) and 94%/96% Sensitivity/Specificity for AHI>=15. The Pediatric sample showed 87%/93% Sensitivity/Specificity staging, 89%/98% Sensitivity/Specificity AHI>=15. Observed Accuracy was >90% for Adults and Pediatrics all 26 events and 7 AHI-categories analyzed, except REM-AHI>=5 (85%/82% Adults/Pediatrics). Conclusion We provide clinical validation evidence that demonstrates interoperable A.I. scoring performance in representative Adult and Pediatric patient clinical PSG samples when compared to prospective, double-blind scoring panel. Support (if any):

Quantification of Blood Flow in Dialysis Access Using Custom-Acquisition Protocol and Imaging Methods: A Clinical Validation Study

2019 ◽  
Vol 30 (7) ◽  
pp. 1062-1068.e2 ◽  
Author(s):  
Nischal Koirala ◽  
Nikunj Chauhan ◽  
Dustin Thompson ◽  
Zahra Karimloo ◽  
Kevin Wunderle ◽  
...  
Keyword(s):  
Blood Flow ◽  
Validation Study ◽  
Dialysis Access ◽  
Clinical Validation ◽  
Acquisition Protocol ◽  
Imaging Methods

Axial cortical involvement of metastatic lesions to identify impending femoral fractures; a clinical validation study

2020 ◽  
Vol 144 ◽  
pp. 59-64
Author(s):  
C.W.P.G. van der Wal ◽  
F. Eggermont ◽  
M. Fiocco ◽  
H.M. Kroon ◽  
O. Ayu ◽  
...  
Keyword(s):  
Validation Study ◽  
Femoral Fractures ◽  
Clinical Validation ◽  
Metastatic Lesions ◽  
Cortical Involvement

Clinical validation study to measure the performance of the Nerve Root Sedimentation Sign for the diagnosis of lumbar spinal stenosis

2011 ◽  
Vol 32 (3) ◽  
pp. 470-474 ◽  
Author(s):  
Lukas P. Staub ◽  
Thomas Barz ◽  
Markus Melloh ◽  
Sarah J. Lord ◽  
Mark Chatfield ◽  
...  
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Validation Study ◽  
Nerve Root ◽  
Clinical Validation ◽  
Lumbar Spinal

MRI-based computational fluid dynamics for diagnosis and treatment prediction: Clinical validation study in patients with coarctation of aorta

2014 ◽  
Vol 41 (4) ◽  
pp. 909-916 ◽  
Author(s):  
Leonid Goubergrits ◽  
Eugenie Riesenkampff ◽  
Pavlo Yevtushenko ◽  
Jens Schaller ◽  
Ulrich Kertzscher ◽  
...  
Keyword(s):  
Fluid Dynamics ◽  
Computational Fluid Dynamics ◽  
Validation Study ◽  
Diagnosis And Treatment ◽  
Coarctation Of Aorta ◽  
Clinical Validation ◽  
Treatment Prediction
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