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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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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 P20 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.

The provided text does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the typical sense of a clinical trial evaluating diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the document is a 510(k) summary for a SonoScape P20 series Digital Color Doppler Ultrasound System, focusing on demonstrating substantial equivalence to a predicate device (SonoScape P50 Digital Color Doppler Ultrasound System K170999).

The "studies" described are primarily non-clinical tests to ensure safety and performance according to established standards, rather than clinical efficacy or diagnostic accuracy studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for imaging performance (like sensitivity or specificity) for clinical applications. Instead, it states that the device was evaluated for its ability to meet design specifications and relevant safety and performance standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "No clinical testing was required." The "test set" in this context refers to the non-clinical evaluations to confirm adherence to engineering and safety standards. There is no mention of a patient-based test set or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed to establish diagnostic ground truth. The "ground truth" for the non-clinical tests would be the specifications of the standards (e.g., a certain level of electrical safety, a specific acoustic output).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing was performed requiring adjudication of diagnostic findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a diagnostic ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests conducted, the "ground truth" or reference was the technical specifications of the device and the requirements of the referenced international and national standards (e.g., IEC 60601-1, ISO 10993-5, AIUM/NEMA UD 2).

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (ultrasound system), not a machine learning algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. No training set was used in the context of machine learning. The "truth" for device design and verification is established through engineering principles and compliance with recognized standards.

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