(8 days)
ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.
ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies.
ComPACS is a modular software device composed of different software modules operating in synergy and each responsible of different functions. The modules can be distinguished into general review station components, analysis components, reporting components, server components and gateway components.
General Review Station Components: CornPACS viewer constitutes the basic module for a review station providing viewing capabilities and retrieving capabilities from DICOM files in removable media. ComPACS Archive introduces archiving and retrieving of studies on the local review station. ComPACS Net Client allows a review station to archive and retrieve studies from a ComPACS Net Archive or from a third party DICOM compliant PACS. ComPACS Multi-Media extends ComPACS Archive to import and archive multi-media files with conversion to the DICOM format. ComPACS audio introduces digital audio management capabilities.
Analysis Components: The review station can be extended with different analysis modules. ComPACS QCA and ComPACS LVA provide respectively quantitative coronary analysis and left ventricular analysis on angiographic images. ComPACS Echocardiac, ComPACS Stress Echo provide different echo analysis features. ComPACS IVUS allows measurements and longitudinal image reconstruction on IVUS images.
Reporting Components: ComPACS Reporting allows report creation and management. This component can be further subdivided into subcomponents in relation to the different type of reports: Generic, Echocardiac, angiographic, etc. ComPACS Dictation extends the reporting module to allow for audio dictation into the report.
Server Components: ComPACS Net Archive is the basic server modules allowing and retrieving of studies from remote workstations equipped with a ComPACS Net Client module. ComPACS Security introduces user activity logging and user rights profiles management. ComPACS Storage Server provides DICOM network storage services as SCP. ComPACS Dictation Server manages the dictated reports and transfers them to an external transcription service. ComPACS Small Business Server and ComPACS Enterprise Server provide DICOM network services for small and large size networks respectively.
Gateway Components: ComPACS Recorder is a device capable of digitizing analog video signals and converting to DICOM compliant files for storage on media or network transfer to a DICOM server.
Here's a summary of the acceptance criteria and study information for the ComPACS device based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a structured table. Instead, it relies on demonstrating substantial equivalence to predicate devices. The core "acceptance criteria" presented throughout the document is that the ComPACS device is "as safe, as effective, and performs as well or better than" its legally marketed predicate devices.
Implicit Acceptance Criteria (based on substantial equivalence claims):
| Criterion Type | Details from Document | Reported ComPACS Performance |
|---|---|---|
| Safety | The device must not introduce new safety concerns compared to predicate devices. | Stated as "does not affect the safety" of the new device and "is as safe" as predicate devices. The advanced image management, wider DICOM support, and broader modality support "add to the safety and effectiveness." |
| Effectiveness | The device must perform its intended functions effectively, comparable to predicate devices. | Stated as "does not affect the... effectiveness" and "is as effective and performs as well or better than" predicate devices. Advanced features (e.g., multi-window/monitor, wider DICOM support, broader modality analysis, audio data management) are stated to "add to the effectiveness" of the device. |
| Intended Use | To be used by qualified medical professionals for capturing, archiving, viewing, processing, analyzing, reporting, and communicating medical digital studies (e.g., cardiac catheterization, echocardiography, general radiological studies). | ComPACS is described as fulfilling this intended use. It is a "software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies." This functionality is stated as equally performing compared to predicate devices. |
| Technical Equivalence | Image storage, query, retrieval, and DICOM network connectivity similar to predicate devices. DICOM format support and proprietary format support (DSR-TIFF, DEFF) similar to predicate devices. Range of search criteria for study query purposes similar to predicate devices. Multi-window and multi-monitor display capabilities comparable to predicate devices. | ComPACS performance for image storage, query, and retrieval, including DICOM network connectivity, was tested using image sets from different imaging devices from various manufacturers. It showed "wider support of both DICOM formats and proprietary formats (DSR-TIFF, DEFF) and in a wider range of search criteria for study query purposes." It also has "added support in ComPACS multi-window and multi-monitor display" compared to its own past product (In-Vision View). |
| Analysis Support | Ability to perform analysis on different types of image modalities. | ComPACS "appears to provide analysis support for a wider set of modalities than any of the single equivalent devices although there no modality for which ComPACS provides unique support." This is stated to "add to the effectiveness of the device without compromising the safety." Specific modules mentioned include QCA, LVA, Echocardiac, Stress Echo, and IVUS. Also, the device supports measurement functions on IVUS images (equivalent to In-Vision View). |
| Audio/Reporting | Management of audio data and report dictation. | ComPACS offers management of audio data and report dictation, which is noted as "adding to the effectiveness of the device." |
Study Details
The document describes non-clinical tests to demonstrate substantial equivalence, rather than a traditional comparative effectiveness study with specific endpoints like sensitivity or specificity.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of cases or images.
- Data Provenance: The document states that "image storage, query and retrieval, including DICOM network connectivity, have been tested using image sets from different imaging devices from different manufactures." This implies a diverse set of images, but no specific countries of origin or whether the data was retrospective or prospective are mentioned. The nature of the device (PACS software) suggests testing would likely involve retrospective imaging data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment focused on functional and technical equivalence rather than diagnostic accuracy that would typically require ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. The non-clinical tests described focus on software functionality (e.g., DICOM compliance, image display, archival) rather than clinical accuracy adjudicated by a consensus method.
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 was done or described. The device is a Picture Archiving and Communication System (PACS) software with analysis modules, not an AI-assisted diagnostic tool for human readers in the sense of improving their diagnostic performance. The document focuses on the device's performance and capabilities being equivalent or superior to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in spirit. The "non-clinical tests" evaluated the ComPACS software's functionality in a standalone manner, assessing its ability to store, query, retrieve, display, and analyze images according to its specifications and in comparison to predicate device capabilities. The document asserts that ComPACS "performs as well or better than" predicate devices on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional and technical tests described (e.g., DICOM compliance, image display, archival, processing), the "ground truth" would be the expected functional behavior and technical standards (e.g., DICOM standard compliance, successful image retrieval, correct display of image content, accurate execution of analysis algorithms). It does not appear to involve clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- Not applicable / Not provided. The ComPACS device is a PACS system and analysis software, not a machine learning or AI algorithm that would typically require a "training set" in the context of learning from data. Its functionality is based on programmed logic and adherence to standards rather than learned patterns.
9. How the ground truth for the training set was established:
- Not applicable / Not provided for the same reasons as in point 8.
§ 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).