(15 days)
ENsphere™ Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to process, analyze, and display medical images. When interpreted by a nuclear physician, the results obtained by using the ENsphere Tempo applications may be used as a tool in determining a patient's diagnosis. ENsphere Tempo should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
This workstation is intended to be operated in a hospital, clinic, or doctor's office. Patient data may be transferred via DICOM over Local Area Networks (LAN), or Wide Area Networks WAN. The primary users of this product include nuclear medicine technologists who process the data and physicians who display, review, and interpret the processed image data.
ENsphere™ Tempo is a Windows®-based Nuclear Mcdicine workstation specific for the Cardiology market segment. The computer system will consist of a Hewlett Packard XW4100 workstation or equivalent. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report gencration and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
The provided document (K040142) is a 510(k) Premarket Notification for the ENsphere™ Tempo Cardiology Workstation. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information regarding
acceptance criteria, specific studies proving the device meets acceptance criteria, sample sizes for test/training sets, or details about ground truth establishment or expert involvement.
The 510(k) summary focuses on demonstrating substantial equivalence based on similar intended use, technological comparison, and system performance to previously cleared predicate devices (Pegasys Ultra™ K993946 and ENsphere™ Physician Desktop Review K021669).
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported performance, or details about the studies (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance), as this information is not present in the provided text.
The information provided only includes:
- Device Description: ENsphere™ Tempo is a Windows®-based Nuclear Medicine workstation for cardiology, allowing image review, processing, post-processing, hardcopy production, interpretation, report generation, and data management.
- Intended Use: A nuclear medicine image processing and display workstation with cardiology-specific software applications to process, analyze, and display medical images. Results are used by a nuclear physician as a tool for patient diagnosis. It should be operated by qualified healthcare professionals.
- Technological Comparison: The device is compared to predicate devices ENsphere™ (Physician Desktop Review K021669) and Pegasys Ultra™ (K993946), stating similar indications for use, overall function, display, review, processing applications, data storage, and system utilities.
§ 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).