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The HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation of the HI VISION Ascendus are B mode. M mode. PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

An ultrasound system consists of the following:

• . Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
• . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
• . A video monitor with optional image recorder to display the computed image or derived Doppler data

The provided document is a 510(k) premarket notification for the "HI VISION Ascendus Diagnostic Ultrasound Scanner". This document establishes substantial equivalence to a predicate device and details the intended uses and technical characteristics. It does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on establishing equivalence rather than presenting performance metrics against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: This information is not present. No specific test set or data provenance is mentioned as there's no performance study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. Ground truth establishment is not discussed.
4. Adjudication method for the test set: This information is not present. Adjudication methods are not discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The document describes a diagnostic ultrasound scanner, not an AI-assisted device, and no MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present. This is not an AI-algorithm submission.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device (HI VISION Preirus Diagnostic Ultrasound Scanner K093466) based on identical technological characteristics and similar intended uses. The "scientific concepts" and "physical and performance characteristics" sections provide a general overview of ultrasound operation but do not detail specific performance studies or acceptance criteria for this new device submission.

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