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eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules 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). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.

eFilm Workstation with Modules is one of the components of a PACS (Picture Archiving and Communications System). eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application image viewing and manipadian in are acquired and stored on an image server in DICOM and/or other proprietary formats. eFilm Workstation with Modules can 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 describes a 510(k) premarket notification for "eFilm Workstation with Modules," a Picture Archiving Communications System (PACS) software application. However, the document does not contain any information about acceptance criteria, device performance, a study to prove these criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance.

The document primarily focuses on:

• Device Description: Explaining what the eFilm Workstation with Modules is (a software application for viewing, processing, and displaying medical images within a PACS system).
• Indications For Use: Stating its intended use for viewing medical images from various sources by medical professionals.
• Technological Characteristics: Highlighting its standalone nature, digital image processing, and network transmission capabilities.
• Testing (General Statement): Mentioning that it's "tested according to the specifications that are documented in a Software Test Plan" as part of their software development process, but provides no details of the testing or results.
• Conclusion of Substantial Equivalence: Affirming that the device is substantially equivalent to a predicate device (eFilm™ Workstation™ K012211 from eFilm Medical Inc.).
• FDA Communication: The FDA's letter confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and performance studies because this data is not present in the provided text. The document is a regulatory submission for substantial equivalence based on the device's technical characteristics and intended use being similar to an already cleared predicate device, rather than a submission detailing clinical performance studies with specific metrics.

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