(37 days)
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
AMICAS PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Typical users of AMICAS PACS 6.0 are radiologists, technologists and clinicians.
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies. AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA,
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
This document is a 510(k) summary for the AMICAS PACS 6.0, a Picture Archiving Communication System. It does not contain specific acceptance criteria or an explicit study demonstrating the device meets those criteria, as typically found in a clinical trial report.
The information provided describes the device, its intended use, general safety considerations, and the testing methodologies employed during its development (functional testing, unit testing, design validation in real-life client environments by licensed physicians). However, it does not present a measurable set of acceptance criteria with corresponding study results.
Here's an breakdown of why the requested information cannot be fully extracted from the provided text, and what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as a measurable set of performance targets. The safety and effectiveness are assessed against the predicate device, AMICAS Vision Series PACS 5.5, and compliance with various regulatory requirements (DICOM, MQSA, FDA-cleared monitors).
- Reported Device Performance: No specific quantitative performance metrics are provided. The document focuses on the process of testing and validation rather than the results against predefined criteria.
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 for Test Set: Not specified. "Design Validation activities... consist of testing in real-life client environments by Licensed Physicians" implies a test set, but its size is not mentioned.
- Data Provenance: Not explicitly stated. The testing was done in "real-life client environments," suggesting clinical data, but no details on source (e.g., country of origin, retrospective/prospective nature).
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: Not specified. "Licensed Physicians" are mentioned as validating the design, but their number and specific qualifications (e.g., years of experience, specialty) are not detailed.
- Qualifications of Experts: Only "Licensed Physicians" is stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No specific adjudication method is mentioned. The design validation involves "Licensed Physicians" but the process by which their feedback or interpretations were combined or adjudicated is not described.
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
- No MRMC comparative effectiveness study is mentioned. This document describes a PACS system, not an AI/CAD system for which such studies are common. It receives data from FDA-cleared CAD systems, but does not perform CAD itself or claim to improve human reader performance with its own AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. AMICAS PACS 6.0 is a PACS system designed for human interpretation, not a standalone algorithm performing automated diagnosis. Its function is to display images and data, facilitating human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given it's a PACS system for display and interpretation, the "ground truth" during its "design validation" would likely involve assessing the accuracy of image display, data integrity, and workflow functionality, as determined by the "Licensed Physicians" against expectations of suitable clinical use. It doesn't involve establishing a diagnostic "ground truth" (like pathology) for the PACS itself.
8. The sample size for the training set
- Not applicable. This is a PACS software, not an AI model that requires a training set in the conventional sense. The "training" here refers to software development and internal testing cycles ("Unit Testing," "Functional testing").
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8. The "ground truth" for software development and testing would be its compliance with "Software Requirements Specifications" and "VDEV" (Vision Development Elaboration Validation) processes.
Summary:
The provided 510(k) summary for AMICAS PACS 6.0 primarily focuses on regulatory compliance, device description, safety considerations, and the internal software development and testing processes. It confirms that the device was deemed "substantially equivalent" to a predicate device (AMICAS Vision Series PACS 5.5). However, it does not contain detailed information on clinical study designs, acceptance criteria with quantitative performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to clinical diagnostic accuracy studies, as those are typically required for diagnostic algorithms rather than image display and archival systems like a PACS.
§ 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).