(45 days)
GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
The provided document, K131514, is a 510(k) Premarket Notification for the GE Vivid E9 Diagnostic Ultrasound System. This document does not describe a study proving a device meets specific performance acceptance criteria for a new AI or advanced algorithm feature. Instead, it is a submission for a modified ultrasound system, primarily focusing on the addition of new transducers and two optional plug-in features (TomTec 4D MV Assessment and StereoVision) that were previously cleared.
The core of the submission revolves around demonstrating substantial equivalence to predicate devices. This means that GE Healthcare is asserting the modified Vivid E9 is as safe and effective as existing legally marketed devices, and does not raise new questions of safety and effectiveness. This is fundamentally different from a study proving a novel device or AI algorithm meets specific performance acceptance criteria.
The document explicitly states: "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." This indicates that no specific clinical performance study was conducted to establish acceptance criteria for a new feature demonstrating its performance.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document because it outlines a regulatory submission for device modifications based on substantial equivalence, rather than a clinical performance study for a new or significantly modified feature.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.