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The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

The SonoMax Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic lmaging modes or a combination of these mode.

The FDA 510(k) summary for the SonoMax Series Digital Color Doppler Ultrasound System (K233697) indicates that no clinical testing was required to demonstrate substantial equivalence. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria beyond non-clinical testing and comparison to a predicate device.

Specifically, under "7. Clinical Test:" on page 6, it explicitly states: "No clinical testing was required."

Given this, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for the training set from the provided text for this cleared device. The substantial equivalence determination was based on non-clinical tests (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output) and a comparison of the device's technical specifications and indications for use to those of a predicate device (XBit 90 Digital Color Doppler Ultrasound System, K200780).

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