(76 days)
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. General features are as follows:
- Integration to PACS systems and inter-connectivity with DICOM stations.
- Performing queries to storage systems in other workstations and/or servers to retrieve DICOM studies or images.
- Image printing in Windows and DICOM printers.
- Selecting and ordering patient lists by date, study, name, gender or ID number.
- Importing and exporting images to DVD or CDROM in the following modes: DICOM DIR, DICOM files, JPEG or BMP.
- Importing NON-DICOM images to DICOM 3.0 format.
- Transfer of studies, images and reports via e-mail.
- Study Visualization by series.
- Cine feature.
- 3D reconstruction allowing: MPR (Multiplane Reconstruction) .
- Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition.
- Possibility to integrate with a Radiology Information System (RIS).
- Work list follow-up; dictated study, transcribed study, and authorized study.
- Due to its Web features, it is possible to review, change and approve studies remotely.
- Complete Web Windows Presentation Foundation (XBAP) technology application.
- Windows Presentation Foundation desk application.
This document pertains to the FDA 510(k) premarket notification K161518 for the PACS CORE/ENCORE™ system, a Picture Archiving Communications System. Based on the provided text, the device is a PACS workstation for receiving, processing, manipulating, enhancing, storing, and displaying digital medical images and data.
The FDA 510(k) submission for PACS CORE/ENCORE™ focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study with specific acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The core of the evaluation revolves around the software's functionality and safety as a medical image management system.
Therefore, the requested information needs to be interpreted within the context of a PACS system's validation for substantial equivalence, which primarily involves functional testing and safety assessments.
Here's an attempt to extract and infer the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a PACS system and the submission is focused on substantial equivalence based on functional and safety requirements, the acceptance criteria are related to the system's ability to perform its stated functions without significant failures, rather than clinical performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements Met: The device performs all required actions according to the Software Requirements Specification (SRS) and User Manual. | The device has passed all in-house pre-determined testing criteria. The data demonstrates that PACS CORE/ENCORE™ performs all required actions according to the functional requirements specified in the SRS and the User Manual. |
| Safety and Efficacy: No errors with an impact on safety or efficacy. | No errors that had an impact on safety or efficacy were found during testing. |
| Integration with DICOM Systems: Ability to receive DICOM 3.1 medical images and integrate withPACS systems and other DICOM stations. | The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. It offers "Integration to PACS systems and inter-connectivity with DICOM stations." |
| Image Display & Manipulation: Capability to display studies, perform MPR, Cine feature, 3D reconstruction. | The system allows displaying studies, offers Cine feature, and 3D reconstruction allowing MPR. |
| Data Management: Performing queries, importing/exporting images, transferring studies/images/reports. | The system can perform queries to storage systems, import/export images (DVD/CDROM, DICOM DIR, DICOM files, JPEG, BMP), and transfer studies/images/reports via e-mail. |
| Reporting Capabilities: Integrated report feature with transcription, digital dictation, and voice recognition. | Offers "Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition." |
| Remote Access: Web features for reviewing, modifying, and approving studies remotely. | "With its Web features, it is possible to review, modify, and approve studies located in a server." and "Due to its Web features, it is possible to review, change and approve studies remotely." |
| Hazard Analysis: "Level of Concern for potential hazards has been classified as "Moderate"." | The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate"." |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures."
- Sample Size: The text does not specify a numerical sample size for the test set (e.g., number of images, number of cases). The testing appears to be functional and system-level validation rather than a clinical study evaluating diagnostic accuracy on a specific number of patient cases.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "in-house pre-determined testing criteria," it likely involves a combination of simulated data, test data, and potentially a limited set of real patient images for functional verification within a controlled environment, rather than a large-scale clinical dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is typically not applicable to the validation of a PACS system for substantial equivalence by the FDA. PACS systems are image management tools, and their "ground truth" during testing is typically whether they correctly display, process, store, and transmit images according to technical specifications. It does not involve expert readers establishing a diagnostic ground truth for disease states. Therefore, the document does not mention experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for this type of system validation. Adjudication methods (like 2+1, 3+1) are used in clinical studies where there's disagreement among human readers interpreting medical images to establish a consensus ground truth. This is not described for the PACS CORE/ENCORE™ testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. Such studies compare the diagnostic performance of human readers with and without AI assistance or different devices. This FDA submission is for a PACS system, which is a foundational imaging infrastructure tool, not a diagnostic AI algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, an algorithm-only (standalone) performance study was not done. The PACS CORE/ENCORE™ is a system for managing and displaying images, not a standalone diagnostic algorithm. The indications for use explicitly state that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," confirming a human-in-the-loop approach for image interpretation.
7. The Type of Ground Truth Used
The "ground truth" for the PACS CORE/ENCORE™ system's testing would be:
- Functional Specifications: Whether the system correctly performs each function as defined in its Software Requirements Specification (SRS) and User Manual (e.g., Does it display the image correctly? Does MPR work as expected? Can it query the archive?).
- Technical Compliance: Adherence to standards like DICOM 3.1 for image handling and communication.
- Safety Requirements: Absence of errors that compromise patient safety or data integrity.
It is not a clinical ground truth like pathology, expert consensus on disease, or patient outcomes data.
8. The Sample Size for the Training Set
The document does not mention a "training set" because PACS CORE/ENCORE™ is not an AI/Machine Learning diagnostic device that requires a training set. The system is validated based on its adherence to functional and safety requirements, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).