(79 days)
The Kodak DirectView PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.
Eastman Kodak DirectView PACS/Image Management System (DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.
The provided text is a 510(k) summary for the Kodak DirectView PACS/Image Management System. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, rather than for proving specific performance criteria with detailed studies or clinical trials as might be required for a PMA (Premarket Approval) application.
Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, specific device performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods for demonstrating a specific level of diagnostic accuracy or clinical effectiveness.
The summary states:
- Intended Use/Device Description: The system is intended to "provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities."
- Substantial Equivalence Summary: "The DirectView PACS/Image Management System is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The comparison listed in Section 3.3 clearly demonstrates that DirectView PACS/Image Management System is substantially equivalent in all areas such as functionality, user/software features, hardware components and connectivity."
Based on the provided text, a table of acceptance criteria and reported device performance, and details about a study proving these criteria, cannot be extracted. The document focuses on demonstrating substantial equivalence to existing PACS systems, which means it asserts that the new device is as safe and effective as a legally marketed predicate device, rather than providing independent performance metrics against predefined acceptance criteria for a new clinical claim.
Specifically, the document does not provide any of the following requested information:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
This is a typical characteristic of a 510(k) submission for an imaging management system (PACS), where the focus is on functional equivalence and interoperability standards (like DICOM) rather than clinical diagnostic performance studies that would measure metrics like sensitivity, specificity, or AUC against a ground truth.
§ 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).