(218 days)
The Acies is a software product. It is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
The Acies is the software that is intended to configure PACS ( Picture Archiving and Communications System ) using a normal Windows-based PC. The workstation on which this software is installed can be utilized as the server-client front-end PC with the function of the Image server and the Viewer to read the image stored in the server. In addition, it is capable to read the image from the client PC through the network. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or DICOM based interface standards. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. The system is also capable of displaying the diagnostic image on the display screen by receiving DICOM SR from FDA approved CAD (Computed Aided Detection) processor.
This document is a 510(k) premarket notification for a Picture Archiving and Communications System (PACS) called "Acies." As such, it describes the device's intended use and claims substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and performance metrics for a novel AI/CAD device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI/CAD device cannot be extracted from this document.
The document focuses on:
- Device Identification: Company, submitter, trade name, common name, classification, product code.
- Device Description: The Acies is software for configuring a PACS, enabling processing and presentation of medical images from various modalities, interfacing with storage/printing via DICOM. It explicitly states that lossy compressed mammographic images must not be reviewed for primary interpretation and that mammographic images require FDA-approved monitors with specific resolution. It also mentions displaying diagnostic images from FDA-approved CAD processors.
- Indications for Use: Primarily facilitates processing and presentation of medical images on suitable display monitors, interfacing with various modality systems and storage/printing devices using DICOM.
- Substantial Equivalence: Compares the Acies to existing predicate devices (HOLOGIC SecurView DX, K062107 and KONICAMINOLTA REGIUS Unitea / ImagePilot, K071436), claiming similar indications for use, technological characteristics, and stating that verification and validation testing showed no safety/efficacy issues.
- Conformance to Standards: Lists several relevant standards (IEC 62304, ISO 14971, ISO/IEC 10918-1, DICOM).
- Conclusion: Reaffirms substantial equivalence to predicate devices.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
In summary, this document does not contain the information required to answer your specific questions related to AI/CAD device performance studies. It is a regulatory submission for a PACS system, not a study report validating an AI algorithm's diagnostic performance.
§ 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).