(29 days)
Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and database management of digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification, and reporting. Merge Cardio software runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols. The modular design allows configurability to tailor the image import and communications solution to the needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The
system offers standard image
controls such as brightness
contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
The provided document, K192276 for Merge Cardio, does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. Instead, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.
This document explicitly states:
- "Summary of Clinical Tests: The subject of this premarket submission. Merge Cardio, did not require clinical studies to support substantial equivalence." (Page 10)
- The non-clinical testing performed includes: Risk Analysis, Requirements Review, Design Reviews, Unit level code reviews, Integration testing, Performance testing, and Safety testing from risk analysis. (Page 9-10)
- The device is a "Picture archiving and communications system (PACS)" (Page 5), which is software designed for managing medical images and data, rather than an AI/ML-driven device with performance metrics like sensitivity, specificity, or AUC as primary acceptance criteria.
While the document details many system features and functionalities, it does not present acceptance criteria in the form of quantitative performance targets (e.g., sensitivity, specificity, or accuracy) that would be typically found for diagnostic AI/ML models. It focuses on functional equivalence to a predicate device.
Therefore,Based on the provided text for K192276, I cannot fulfill the request for information regarding acceptance criteria and the study proving the device meets them in the context of an AI/ML diagnostic system. The document does not describe such a study or criteria for this specific 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).