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The Versana Premier 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 Premier 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 access). Modes of operation include : B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.

The Versana Premier 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. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual 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 during scanning. The system has a HDMI port, VGA connection port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) Premarket Notification Submission for the GE Versana Premier ultrasound system. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a new AI-powered diagnostic device meets specific performance acceptance criteria through a dedicated clinical study.

Therefore, the information required to populate the fields related to acceptance criteria, ground truth, sample size, expert adjudication, and comparative effectiveness studies is not present in this document. The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."

The only mention of an "Artificial Intelligence (AI) feature" is "Whizz Label," and no performance data or study details are provided for this feature. The document indicates that the Versana Premier employs "the same fundamental scientific technology as its predicate device and reference devices," and that it is "substantially equivalent ... with regard to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness."

Here's what can be extracted from the document regarding the AI feature, acknowledging the absence of the requested study details:

• AI Feature Mentioned: Whizz Label is an Artificial Intelligence (AI) feature that is being added.

All other requested information cannot be found in the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Explicitly stated that clinical studies were not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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