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Vivid S60N/Vivid S70N 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 and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obsterics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Dopler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel. LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE (Intra Cardiac Echocardiography) transducers.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

This document is a 510(k) summary for the GE Medical System Ultrasound and Primary Care Diagnostics, for the device names Vivid S60N / Vivid S70N.

Based on the provided text, the device itself is an ultrasound system, not an AI/ML-driven device. The document explicitly states:

• "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence." This indicates that a clinical study, including any form of ground truth establishment, expert review, or MRMC study, was not performed for this submission. The substantial equivalence was based on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety compliance with standards).

Therefore, it is not possible to provide the requested information related to acceptance criteria, ground truth, expert adjudication, or clinical study results for an AI/ML device, as this pertains to a conventional ultrasound system and the submission did not rely on such clinical data for its clearance.

The document describes the device, its intended use, and its substantial equivalence to a predicate device, primarily based on the fact that its underlying technology, intended use, and capabilities are similar to already cleared devices, and it meets relevant safety and performance standards.

In summary, none of the requested information (acceptance criteria, test set, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is available in this document because the device is a conventional ultrasound system that did not undergo a clinical study for this 510(k) submission.

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