(37 days)
The EchoConnex Communicator System is a Windows 2000/Windows XP software application package. It is designed to view, quantify, transfer and store image data acquired on medical imaging devices.
The EchoConnex Communicator software provides a means of opening and displaying image files. The EchoConnex Communicator software provides a means of transferring medical image files using a DICOM network method from the acquisition devices to the Connex Acquisition Server. The Connex Acquisition Server provides a means for transferring the acquired studies to the Connex Central Server using standard networking methods.
The EchoConnex Communicator software provides a means to retrieve and view image data located on one of the Connex server devices using a standard network connection. The EchoConnex Communicator software provides a means for querying and retrieving patient studies from a networked DICOM server device.
The EchoConnex Communicator software provides a means of creating AVI, BMP, TIFF and JPG graphic files from the image data displayed by the software. The EchoConnex Communicator software provides a means of quantifying the image data using standard measurement tools.
The provided text is a 510(k) Summary for the EchoConnex Communicator software. It primarily focuses on demonstrating substantial equivalence to a predicate device and software development processes, rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information is not available in the provided document.
Here's a breakdown of what can and cannot be answered based on the text:
Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report specific performance metrics for the EchoConnex Communicator software beyond compliance with voluntary standards (ISO JPEG and DICOM 3.0) and general functionality description. It emphasizes substantial equivalence to a predicate device rather than independent performance validation against predefined criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in the document. The device is designed to comply with ISO JPEG and DICOM Standard 3.0. | The device provides means for opening, displaying, transferring, retrieving, viewing, querying, creating graphic files (AVI, BMP, TIFF, JPG), and quantifying image data using standard measurement tools. It adheres to ISO JPEG and DICOM 3.0. |
Study Information
Since no specific performance study against acceptance criteria is detailed in the document, most of the following information is not available:
- Sample size used for the test set and the data provenance: Not mentioned. The document relies on substantial equivalence to a predicate device, not a new performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The EchoConnex Communicator is a PACS workstation, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/mentioned. This is a viewing and communication system, not a standalone diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable/mentioned. This is not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable/mentioned.
Summary of available information:
The document describes the EchoConnex Communicator as a Picture Archiving and Communications Systems Workstation designed to view, quantify, transfer, and store image data acquired on medical imaging devices. It claims substantial equivalence to the CardioNow Cardiology Wide Area Network Archive and Retrieval System. The software development followed documented processes for design, verification, and validation, including a risk assessment. Compliance with ISO JPEG and DICOM Standard 3.0 is stated as a design goal. However, no specific performance study against defined acceptance criteria is presented in this 510(k) summary. The submission focuses on the device's functionality and adherence to established communication standards, rather than clinical performance metrics.
§ 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).