(15 days)
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The document is a 510(k) summary for the eFilm™ Workstation, a Picture Archiving Communications System (PACS), seeking substantial equivalence to a predicate device.
Here's a breakdown of why the requested information cannot be provided from the given text:
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A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on describing the device, its intended use, and its technological characteristics as compared to a predicate device. It briefly mentions "Testing" as an integral part of the software development process according to documented specifications but does not provide any specific performance criteria or results.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is detailed for any performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Since no performance study or test set is described, there's no mention of experts or their qualifications for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is mentioned.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC study or any comparative effectiveness study with human readers, with or without AI assistance, is not described. The eFilm™ Workstation is a PACS viewing software, not an AI-assisted diagnostic tool in the context of this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study is indicated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, the type of ground truth used is not specified.
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The sample size for the training set: There is no mention of a training set as no machine learning or AI algorithm development is described that would require one.
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How the ground truth for the training set was established: No training set is mentioned, so no ground truth establishment for it is described.
In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and indications for use, rather than a performance study report with specific acceptance criteria and results.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).