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Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is applicable for adults. It is intended for use in abdominal, superficial organs, trans-rectal, musculo-skeletal, peripheral vessel, urology exams.

Modes of operation include: B, B+C, B+C+D(PW), B+M Mode, Image fusion, Needle Line.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is a medical, real-time, high-resolution ultrasound diagnosis system. It has a 24" multi-directional swiveled (non-touch) LCD monitor, a secondary 17" touch-display and cart. The System offers B, C, D, M Mode, as well as FUSION Mode which could synthesis real-time US images and preoperative images, such as CT and MRI. It could be equipped with convex-array, linear-array and intracavitary tracked probes, that supporting a wide range of clinical applications.

The provided FDA 510(k) clearance letter for the Venus Ultimate Diagnostic Ultrasound System does not contain information regarding the acceptance criteria for an AI/CAD (Computer-Aided Diagnosis) component or a study proving that such a component meets acceptance criteria.

The document primarily focuses on demonstrating the substantial equivalence of the Venus Ultimate Diagnostic Ultrasound System to a predicate ultrasound device (Resona R9S) based on:

• Indications for Use: Comparing the intended clinical applications.
• Operating Modes: Comparing the types of imaging modes available (B, C, D, M, etc.).
• Functions: Comparing features like Image Fusion and Needle Line/Biopsy Guidance.
• Non-Clinical Testing: Conformance to various safety, electrical, biological, and acoustic output standards.

Specifically, Section 8, "Clinical Studies," explicitly states: "Not applicable. The subject of this submission, Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

This indicates that the clearance was based on similarity to existing ultrasound technology and adherence to performance and safety standards for the generalized ultrasound system itself, not on the performance of a specific AI algorithm or CAD feature that would require a clinical validation study with detailed acceptance criteria.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because the provided text does not describe a clinical study for an AI/CAD component.

To answer your request, the input document would need to describe a specific AI or CAD feature within the ultrasound system and the clinical study conducted to validate its performance against defined acceptance criteria.

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