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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, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

This SonoScape S60 Elite 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. 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.

The medical device in question is the Sonoscape S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059).

Based on the provided document, here's the information regarding its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document states that non-clinical tests (electrical safety, EMC, acoustic, biocompatibility, software verification/validation) were performed.
• No clinical testing was required for this 510(k) submission.
• Therefore, there is no specific "test set" in terms of patient data for an AI algorithm as typically understood in such studies. The evaluation focused on engineering and performance parameters against established standards.
• Data provenance: Not applicable as no clinical data test set was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. Since no clinical test set was utilized and no AI algorithm with independent ground truth establishment was conducted, there were no experts needed to establish ground truth for a clinical test set. The device is an ultrasound system, not an AI diagnostic tool requiring clinical ground truth for performance evaluation in this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or subjective interpretations requiring adjudication were part of this 510(k) submission.

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:

• No. An MRMC comparative effectiveness study was not performed. This submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader performance with and without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This is not an AI algorithm. It is a digital color Doppler ultrasound system. The evaluation was of the system's compliance with safety and performance standards.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was based on the requirements and methodologies outlined in the specified international medical device standards (IEC, ISO, AIUM/NEMA). These standards define objective parameters and testing procedures for assessing the safety and performance of ultrasound systems.

8. The Sample Size for the Training Set:

• Not applicable. This submission does not pertain to an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no AI algorithm training set, no ground truth needed to be established for it.

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