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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape P50 series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 25.0 MHz. This system consists of a mobile console with touch screen and 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 data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

This is a 510(k) Pre-market Notification for the SonoScape P50 Series Digital Color Doppler Ultrasound System. It asserts substantial equivalence to a predicate device and does not involve AI/ML. Therefore, the questions related to AI/ML acceptance criteria and studies are not applicable.

The document focuses on the intended use, technical characteristics, and safety standards of the ultrasound system and its various transducers. It demonstrates that the device is substantially equivalent to a previously cleared device (SonoScape S45 Digital Color Doppler Ultrasound System K160283) in terms of its intended use, technical specifications, and probe functionality. The "Remark" column in the probe comparison tables refers to "SE Analysis," indicating the substantial equivalence analysis rather than AI/ML performance metrics.

Specifically, the document states:

• No clinical testing was required.
• It does not mention any AI/ML components or features, nor does it define or describe acceptance criteria related to AI/ML performance.
• The non-clinical tests relate to electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output, conforming to relevant IEC, ISO, AIUM, and NEMA standards.

Therefore, the requested information pertaining to AI/ML acceptance criteria and studies (such as sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as it does not describe an AI/ML device.

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