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The Color Doppler Ultrasound Diagnostic System is a general-purpose ultrasound system. 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.

The systems support the following clinical applications:

Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD.

The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.

It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.

The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.
Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.

With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. abundant image processing functions. It is convenient for choice of optimal diagnostic image with perfect image pigeonhole, browse, management functions. Measure, calculation, and report are even complete and convenient with powerful measure software package and perfect measurement.

The device supports linear probe and convex probe. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology etc. .

The provided text is a 510(k) Summary for a Color Doppler Ultrasound Diagnostic System. It aims to demonstrate substantial equivalence to a predicate device and includes information on non-clinical testing and a comparison table. However, it explicitly states:

"No clinical study is included in this submission."

This means there is no information provided in the document regarding acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications and intended use, not clinical efficacy or performance.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

The closest information provided is:

• Non-Clinical Test Conclusion: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• Applied Standards: A list of standards indicating safety and performance compliance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-5, ISO 10993-10, IEC 62133-2, IEC TR 60601-4-2). These standards typically involve technical performance and safety assessments rather than clinical performance acceptance criteria.
• Acoustic Output within FDA guidelines: $Ispta.3 \le 720 mW/cm^2$, MI < 1.9, TI < 6.0. These are safety limits, not clinical performance metrics.

Without a clinical study, the acceptance criteria and performance data requested (e.g., related to diagnostic accuracy, sensitivity, specificity, etc.) are not available in this document.

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