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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic 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), OB/Gyn and Urology.

This SonoScape X5 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 X5 Series system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and auto-correlation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

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 keyboard control panel, power supply module, color LCD monitor and optional probes.

This system (X5 Series Digital Color Doppler Ultrasound System) are additional models (X5 Exp, X5 Pro, X6, X6 Exp, X6 Pro), additional transducers (C1-6, 12L-B, 9L-A, 18L-A, 13L-A, L746, 10L-I, 1012, 6V7, 6V3, 6V3A, C361, VC6-2, C542, C322, 12LT-A, 12LI-A, 6CT-A, 6CI-A, BCC9-5, S1-5, 2P1, CWD5.0, CWD2.0, MPTEE and MPTEE min probes), additional functions (Elastography, Contrast imaging) and updated intended use (Trans-esoph.(Cardiac)) to legally marketed SonoScape X5 (K160258).

The provided document describes the Sonoscape Medical Corp.'s X5 Series Digital Color Doppler Ultrasound System (K182648) and its substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific performance acceptance criteria for a diagnostic AI algorithm.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices by comparing intended use, technical characteristics, and probes, as well as adherence to recognized safety and performance standards. No information regarding an AI algorithm's performance or study details (like sample size for test sets, ground truth establishment, expert qualifications, or MRMC studies) is present.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves an AI device meets these criteria, as the provided text pertains to a general diagnostic ultrasound system and its transducers, not an AI-powered diagnostic tool.

The "Performance test" section under "Non-Clinical Tests" lists compliance with electrical safety, EMC, acoustic testing, and software verification/validation standards, indicating the device meets these standards. However, these are general device safety and performance criteria, not specific diagnostic performance criteria for an AI algorithm.

Disclaimer: The provided document is a 510(k) summary for a medical device and does not contain details about the performance of an AI algorithm or a study testing such an algorithm. The information below is based solely on the content available in the provided text, which primarily addresses the substantial equivalence of a physical ultrasound system to predicate devices. As such, many of the requested fields are not applicable or cannot be extracted from this document because it does not describe an AI medical device or its validation study.

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