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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Trans-rectal, Transvaginal, Peripheral Vascular, Cerebral Vasculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape P10 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 FDA 510(k) summary does not contain performance acceptance criteria or detailed results from a study proving device efficacy. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone efficacy study with concrete performance metrics.

Specifically, the document states:

• "No clinical testing was required." This indicates that no human clinical trials were performed to establish the device's diagnostic performance for its intended use cases against a ground truth.
• "Laboratory tests (including Phantom tests) were conducted to verify that the P10 system met all design specifications and the P10 system conformed to applicable medical device standards." This refers to technical performance verification against engineering specifications and regulatory standards (electrical safety, biocompatibility, acoustic output), not diagnostic accuracy or clinical effectiveness.

Therefore, the requested information regarding acceptance criteria and performance against those criteria through a study with specific sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this product is not available in the provided text. The document is primarily a comparison against a predicate device to establish substantial equivalence.

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