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The Versana Essential is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.

Versana Essential is intended to be used in a hospital or medical clinic.

The Versana Essential is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.

The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.

The operator control panel includes function keys, trackball, an alfa-numeric keyboard.

The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port. The Video adapter is optional part which used to extend the S-Video/Composite Out interface by connecting with HDMI port. The system has a DC outlet to allow connection of a DC printer which sits in the printer box of the console and an option for external Printer USB Isolator for other commercial printers to connect.

The system allows for electronic instructions for use and software updates to be download from a GE Healthcare website.

The provided document is a 510(k) Premarket Notification Submission for the GE Versana Essential ultrasound system. It details the device's technical characteristics, intended use, and argues for its substantial equivalence to a predicate device (Versana Balance K220446).

However, this document does not contain any information regarding acceptance criteria, device performance metrics, or study details (sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance). The "Summary of Clinical Tests" section explicitly states: "The subject of this premarket submission, Versana Essential, did not require clinical studies to support substantial equivalence."

Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria, device performance, or study details.

The document primarily focuses on demonstrating substantial equivalence by comparing the Versana Essential to its predicate device Versana Balance (K220446) based on:

• Intended Use: Stated to be identical.
• Imaging Capabilities: Stated to be the same.
• Technological Characteristics: Stated to be the same fundamental technology, with minor differences in scan channels (Essential has fewer but safety/performance met) and absence of touch panel/Bluetooth in Essential.
• Imaging Modes: Stated to be identical.
• Hardware: Stated to be similar, with compliance to safety standards.
• Software: Stated to have the same features and functionality, with two minor exceptions not available in the Essential (whizz label and multi-touch).

The "Summary of Non-Clinical Tests" lists compliance with various electrical, electromagnetic, biocompatibility, and safety standards, but these are general safety and performance standards for the device as a whole, not specific performance metrics for an AI-powered diagnostic feature.

In summary, the provided text does not describe an AI feature or its associated acceptance criteria and performance study.

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