(9 days)
AGFA's WEB1000 software is intended for installation on standard hardware meeting minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. Images stored on the WEB1000 can be part of your evolving workflow. The WEB1000 can also be used remotely over a hospital intranet or over the Internet.
When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral image data collected from various modalities including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.
WEB1000™ is a software package, which may be marketed as a software only solution, as well was in conjunction with standard PC hardware. WEB1000™ is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to WEB1000™ are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols.
Images sent to WEB1000™ can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The WEB1000™ applet can be used for the purposes of viewing images over a hospital intranet, or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device. WEB1000™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to WEB1000™ . WEB1000™ is intended for reference viewing of medical data. It is not for the purposes of diagnosis. Images viewed from WEB1000™ are used from reference purposes only. Diagnostic reports created from diagnostic viewing application and distributed through WEB1000™ can be used for treatment of a patient.
The provided 510(k) summary for K053458 for the AGFA WEB1000™ device is a summary of safety and effectiveness, focused on establishing substantial equivalence to a predicate device, rather than a detailed report of a study proving the device meets specific performance acceptance criteria.
The submission claims the device is substantially equivalent to General Electric Medical Systems' Centricity™ PACS System (Web Client Component). The basis for this claim is that: "Technological and functional characteristics of the Agfa's WEB1000™ software are identical to those of General Electric Medical Systems' Centricity™ PACS System (Web Client Component)."
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving those criteria are met, sample sizes, ground truth establishment, or expert involvement. The entire premise of this 510(k) is that because it is functionally identical to a previously cleared device, it is considered safe and effective for its stated intended use.
Based on the provided text, the requested information (1-9) cannot be extracted because the submission relies on substantial equivalence to a predicate device and does not present a de novo study with acceptance criteria and performance data.
Here’s what can be inferred from the document regarding the lack of such a study:
- No acceptance criteria or reported device performance are listed. The document states, "The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols." This is a general statement, not a specific performance metric.
- No mention of a study with a test set, data provenance, number of experts, adjudication method, MRMC study, or standalone performance study. The document focuses on technological and functional comparison to the predicate.
- The type of ground truth used is not applicable as no study with a ground truth is described.
- No sample size for a training set is mentioned, nor is how ground truth for a training set was established. This is because the submission is not describing the development and validation of a novel algorithm requiring these details.
In summary, the 510(k) for K053458 is a substantial equivalence submission, which typically does not include the detailed performance study data requested. The "study" here is the comparison of technological and functional characteristics to a predicate device, rather than a performance study against predefined acceptance criteria.
§ 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).