(202 days)
The CARESTREAM 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.
The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.
The CARESTREAM PACS Lightweight Viewer software program is used for patient management by the referral community in order to access and display patient data, medical reports, and medical images from different modalities including CR, DR, CT, MR, NM and US after the primary reading has been completed on dedicated diagnostic workstations.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.
CARESTREAM PACS is an image management system whose intended use is to provide completely scalable 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.
It is a software only solution that contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians. It offers an intuitive user interface which includes a tab concept, grouping features, and functions with the same context together such as Image display, Monitor layout, Comparison, Wide area user tab, etc.
The device provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. It is designed using an open architecture that allows for various proprietary and off the shelf software components to be integrated with off the shelf hardware components and configured meeting the user's specific needs in a single-site or multi-site environment.
Carestream PACS provides support for 3D registration of studies taken at different times or by different modalities for reading of CT/MRI or PET-CT images. The volumetric data sets are synchronized allowing the user to view reformatted series side by side and superimposed images. In all methods the algorithm is only using a rigid space transformation. Automatic vessel segmentation suggests a segmentation that that can either be accepted, ignored or fine tuned by the user.
The CARESTREAM PACS LightWeight Viewer feature addresses the need for a fast and simple web based tool to access patient records and images. It allows for high speed distribution of image data to users in a wide area setup. The software technology uses HTML5 which allows browser enabled devices to run the application without local software installation. The LightViewer has a simple GUI for viewing including zoom, pan, windowing, basic measurements, cine, etc.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It provides a diagnostic viewer of medical images substantially equivalent to the CARESTREAM PACS software, with portable device characteristics and functionality. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. The CARESTREAM PACS LightWeight Viewer software is not to be used for mammography in the US.
Here's a summary of the acceptance criteria and the study details for the Carestream PACS, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific numerical performance results for the device beyond the general statement that "Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."
However, it does describe the types of tests performed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Display Performance (Contrast, Luminosity, Resolution, Noise) | Demonstrated compliance with: |
- IEC 62563-1
- AA PM TG18 guidelines |
| Diagnostic Image Viewing Capabilities | Affirmed by multiple studies with qualified radiologists using various modalities (CR, DR, CT, MR, NM, US) under different environmental conditions. |
| Functionality under Simulated Use Conditions | Testing was conducted under simulated use conditions; predefined acceptance criteria was met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the "multiple studies with qualified radiologists."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. 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)
- Number of Experts: "multiple qualified radiologists" were used. The exact number is not stated.
- Qualifications of Experts: Described as "qualified radiologists." No further details on their experience level (e.g., years of experience, subspecialty) are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth or evaluating reader performance.
5. 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
- MRMC Study: The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study. The studies mentioned focus on affirming the diagnostic image viewing capabilities of the LightWeight Viewer itself, rather than comparing human reader performance with and without AI assistance.
- Effect Size: Not applicable as no such study is described. The device is a PACS viewer, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a PACS viewer with interactive tools, not a standalone algorithm providing diagnostic outputs. Therefore, a standalone algorithm-only performance study as typically understood for AI diagnostic tools would not be relevant or described here. Its functionality aims to ease the process of human analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the "diagnostic image viewing capabilities" were affirmed by "qualified radiologists," suggesting an expert-based evaluation. However, the specific method for establishing a definitive "ground truth" (e.g., consensus, comparison to gold standard, pathology) for the images used in these studies is not detailed.
8. The sample size for the training set
The document does not mention a training set, as the device primarily describes software modifications to an existing PACS system and the development of a viewer. It is not an AI algorithm that would typically require a training set for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned in the context of this device.
§ 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).