(82 days)
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The modified software features provide for the measurement of anatomical structures and for analysis packages that provide information.
The provided text mentions that "The Arterial Health Package software has been verified and validated according to the company's design control process." However, it does not provide specific acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot construct the table or provide the requested information.
The document is a 510(k) summary and an FDA letter of substantial equivalence for a software update to Siemens Diagnostic Ultrasound Systems Arterial Health Package. These documents primarily focus on demonstrating substantial equivalence to previously cleared devices for regulatory purposes. They typically do not contain the detailed performance study results that would include acceptance criteria, specific sample sizes, ground truth methods, or expert qualifications as requested. This information would usually be found in a more comprehensive clinical study report or validation protocol, which is not part of this submission.
§ 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).