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The P12 Elite Series Digital Color Doppler Utrasound System (P12 Exp, P12 Elite, P12 Pro, R12, P12N, P11 Exp, P11 Elite, P11 Pro, R11, P11N, P10 Eirte, P10N, R10, P9 Eirte, M11,R9) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited. The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.

This SonoScape P12 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 Imaging, Elastography, 3D/4D.

The provided text details the P12 Elite Series Digital Color Doppler Ultrasound System and its substantial equivalence to predicate devices, but it does not include a study that proves the device meets specific performance acceptance criteria related to efficacy beyond general safety and electrical standards. The document states "No clinical testing was required" (Section 8).

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative/standalone effectiveness studies is not available in the provided text.

However, the document does list non-clinical performance test results:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable/not specified for performance criteria beyond standards compliance. The document explicitly states "No clinical testing was required." The "test set" in this context refers to the device and its components undergoing engineering and safety evaluations rather than a clinical dataset.
• Data Provenance: Not specified, but likely internal laboratory testing by Sonoscape Medical Corp. (manufacturer's non-clinical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/not specified, as no clinical ground truth was established from expert consensus for device performance. The "ground truth" for the non-clinical tests was the compliance with established engineering and safety standards.

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

• Not applicable/not specified, as individual case-level adjudication by experts was not performed for these non-clinical tests. Compliance was assessed against defined technical standards.

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. The document explicitly states "No clinical testing was required." The device is a general-purpose ultrasound system, not an AI-assisted diagnostic tool discussed in the context of improving human reader performance.

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

• Not applicable. The device is a diagnostic ultrasound system, not an algorithm being tested in a standalone capacity without a human operator. Its performance is assessed through its ability to provide images and measurements for human interpretation.

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

• For the non-clinical tests described, the "ground truth" was compliance with established international and national engineering, electrical, electromagnetic, acoustic output, software, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, AIUM/NEMA UD 2).

8. The sample size for the training set:

• Not applicable. This document describes the regulatory clearance of a medical device (ultrasound system), not the development or validation of a machine learning model that requires a training set.

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

• Not applicable. As above, this document does not concern a machine learning model with a training set.

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The P20 Elite Series Digital Color Doppler Ultrasound System (P25 Exp, P20 Exp, P20 Elite, P22 Elite, P22 Exp, P15 Exp and P15 Elite) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited.

The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging mode, Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

This SonoScape P20 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 Imaging, Elastography, 3D/4D.

The provided FDA 510(k) summary (K221140) describes the Sonoscape P20 Elite Series Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for software performance and acceptance criteria for an AI/ML powered device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, and training set information) is not available in the provided text.

The document discusses general performance tests related to electrical safety, EMC, acoustic testing, and software verification/validation, but these are for the overall ultrasound system's hardware and embedded software, not for an AI/ML algorithm within the system.

The "P20 Elite Series" system includes some "newly added features in Function" such as "contrast imaging, Color 3D, S-Live/S-Live Silhouette/S-Live Contour, S-Depth, STIC, 3D/4D HyCoSy, SPI, Micro F, SR Flow, Auto Face, VCI and etc." and "new features (Measurement Items), including AVC Follicle, Auto OB, Auto NT, Auto EF, Auto bladder, Auto IMT and etc."

For these new functions, the summary states:

• They are "the same as or similar with the imaging functions of the reference device S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for imaging functions.
• They are "the same as or equivalent with the measurement functions of the reference S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)" for measurement items.
• "The differences in function and measurement items will not raise new risk and different questions of safety and effectiveness."
• "The end user can edit, accept, or reject the measurements and can modify the measurement results at any point. The final output and its accuracy is controlled by the end user."

This indicates that these functions are either manual or assisted measurement tools where the final decision rests with the user, and their performance is deemed similar to existing cleared devices, not necessarily validated through specific AI/ML performance studies with acceptance criteria as you've requested.

Conclusion: The provided text does not contain the detailed information regarding acceptance criteria and performance studies for an AI/ML powered device as outlined in your request. The submission focuses on demonstrating substantial equivalence of a general-purpose ultrasound system to a predicate device based on technical characteristics and safety standards.

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