(34 days)
ALZ Web PACS (Version 1.0) is an imaging software system intended to be used by trained healthcare professionals. ALZ Web PACS is used with general purpose computing hardware to acquire, transmit, store, view, and process DICOM images.
This device is not intended for mammography.
The ALZ Web PACS (Version 1.0) is designed for the management, viewing, and processing of DICOM images. The ALZ Web PACS consists of the ALZ Web PACS software application installed on a server and the ALZ Web PACS viewer running on client computers connecting to the server via the HTTPS protocol.
The provided text does not contain any information about specific acceptance criteria, detailed study designs, or performance metrics for the ALZ Web PACS (Version 1.0) beyond a general statement that "The ALZ Wcb PACS was tested to verify that the device meets prospectively defined design and performance specifications. The results of the testing confirmed that the ALZ Web PACS performed as intended."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a 510(k) summary for a Picture Archiving and Communication System (PACS), which typically involves verification and validation activities related to software functionality, compatibility with DICOM standards, and overall system reliability rather than diagnostic performance against a ground truth for a specific medical condition.
If this were a device with specific diagnostic claims, the 510(k) would contain a much more comprehensive description of performance testing, including sensitivity, specificity, accuracy, and detailed study parameters. For a PACS, the "performance testing" referenced is likely focused on:
- Functional Testing: Ensuring all described features (acquiring, transmitting, storing, viewing, processing DICOM images) work as intended.
- Compatibility Testing: Verifying interoperability with various DICOM-compliant modalities and other systems.
- Performance and Load Testing: Assessing speed and reliability under expected usage conditions.
- Security Testing: Ensuring data integrity and patient privacy.
- Usability Testing: Confirming ease of use for trained healthcare professionals.
Without specific details in the provided text, I can only state that the document indicates that performance testing was conducted, and the device met its defined specifications, but no further details are given.
§ 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).