(70 days)
ImageLink™ is an integrated medical imaging solution that allows for the storage, manipulation, and annotation of high resolution digital radiological images from multiple source modalities. It enhances the efficiency of diagnostic decision making and includes a feature-rich viewer with customizable worklists and hanging protocols that can be organized to meet the unique requirements and style of the individual radiologist.
ImageLink is designed to fit seamlessly into the hospital's existing IT infrastructure, integrating with the CPSI HIS/RIS systems. Patient and order information is shared with CPSI clinical applications providing real-time update of the PACS worklist and DICOM Modality Worklist files, notification of completed orders and signed transcriptions, and quick access to the study throughout the enterprise.
This product conforms to recognized industry standards such as DICOM, JPEG, ACR, and others as applicable.
Support for the following modalities will be provided:
- · CR
- · CT
- · MR
- · NM
- RF
- US
- DX
- PT
- XA
- · OT
- · MG
The CPSI ImageLink application software includes the following major components: ImageLink Server, ImageLink Viewer, and ImageLink/ChartLink Interface for web viewing. These software applications, combined with the hardware platform and networking infrastructure, make up the ImageLink System.
The provided documentation does not contain any information about acceptance criteria or a study proving the device meets them. The 510(k) summary for ImageLink (K112096) primarily focuses on:
- Device Description and Intended Use: Explaining what the device is and what it's for.
- Predicate Device Comparison: Establishing substantial equivalence to a previously cleared PACS system (GE Medical Systems, Information Technologies Centricity PACS System K043415).
- Compliance with Standards: Mentioning adherence to standards like DICOM, JPEG, ACR, 21 CFR 820.30, and ISO 14971 for design, development, and risk analysis.
The section titled "F.10 Test Summary" states that "The design and development process of ImageLink™ complies with standards listed in section I of this submission," and mentions adherence to "change control principles based upon 21 CFR 820.30" and "Risk Analysis in ISO 14971." However, these statements refer to process compliance rather than specific performance metrics or a clinical/bench study demonstrating functional equivalence or meeting predefined acceptance criteria for diagnostic performance.
Therefore, I cannot provide the requested information, as it is not present in the given text.
Specifically, the following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: No such table or performance data is presented.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set or ground truth is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool in the sense that would typically require MRMC studies for improved reader performance.
- Standalone performance (algorithm only without human-in-the-loop performance): This is not applicable as the device is a PACS system designed for human interaction and use. No standalone algorithm performance is discussed.
- Type of ground truth used: No ground truth is described.
- Sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No training set or ground truth establishment is described.
The submission focuses on establishing substantial equivalence based on intended use, device description, materials, target population, and environment, along with compliance with relevant medical device regulatory and quality standards for its development. It does not detail specific performance studies or acceptance criteria comparisons that might be expected for an AI-enabled diagnostic 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).