(30 days)
The intended use of the CSV12 Software Viewer is acceptance, transfer, display, storage, and digital processing of Cypress diagnostic ultrasound images and image manipulation and quantification. No new intended uses are claimed for the modifications.
The intended use of the CSV12 Software Viewer is for the acceptance, transfer, display, storage, and digital processing of Cypress Diagnostic Ultrasound System images, including image manipulation and quantification.
This modification is a software-only version of the Acuson Cypress Diagnostic Ultrasound System Image Viewer and is described as the CSV12 Software Viewer.
The modifications implemented in the CSV12 Viewer Software are to provide off-line image management of ultrasound studies and images on a PC and may be operated independently as a software-only product.
The CSV12 Software Viewer, when running on a personal computer (PC) duplicates the patient database, study storage, viewing, and quantification capability of the Cypress ultrasound system. This provides clinicians with a simple means of viewing studies off-line. Because it can read the full-resolution R-Theta file formats of the Cypress diagnostic ultrasound images, the CSV12 Software Viewer displays images in real-time without any compression, duplicating the original quality of the images on the Cypress diagnostic ultrasound system.
The provided document is a 510(k) summary for a software viewer (CSV12 Software Viewer) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information typically found in a study demonstrating how a device meets acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy).
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document. The document describes a software viewer that "duplicates the patient database, study storage, viewing, and quantification capability of the Cypress ultrasound system" and "displays images in real-time without any compression, duplicating the original quality of the images on the Cypress diagnostic ultrasound system." The acceptance criteria for such a device would likely focus on functional equivalence (e.g., ability to open and display images, perform measurements accurately compared to the predicate) rather than diagnostic performance metrics like sensitivity or specificity. No specific quantitative performance metrics are provided.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the document. The filing discusses the software's capabilities but does not detail a formal test set or its provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not present in the document. Since there's no mention of a diagnostic performance study, there's no discussion of ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not present in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done based on the provided document. The filing is for a software viewer and focuses on its functional equivalence, not on improving human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study focused on diagnostic accuracy is not relevant/not mentioned for this device as it is a viewer. The "standalone" aspect described in the document refers to the software being able to "operate independently as a software-only product" on a PC, duplicating the existing ultrasound system's viewing capabilities, rather than a diagnostic algorithm working independently.
7. Type of Ground Truth Used
Ground truth is not applicable/not mentioned in the context of diagnostic performance criteria for this device as described. The focus is on faithful reproduction and functionality of existing images and data.
8. Sample Size for the Training Set
This information is not present in the document. As this is a software viewer that replicates existing functionality, a "training set" in the context of an AI/machine learning algorithm is not applicable or discussed.
9. How the Ground Truth for the Training Set Was Established
This information is not present in the document. See point 8.
§ 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).