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The SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

This SonoScape S12 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 15.0 MHz. This system consists of a mobile console with 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 subject of this submission is the addition of new probes to the legally marketed SonoScape S12.

New probes Add 3C-A, 4P-A and 10l2 probes.

Here's a breakdown of the acceptance criteria and study information for the SonoScape S12 Digital Color Doppler Ultrasound System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the SonoScape S12 Digital Color Doppler Ultrasound System does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages, sensitivity/specificity thresholds) or detailed reported device performance in terms of these metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (SonoScape S12 K142474) and compliance with relevant industry standards. The performance is assessed by confirming that the device meets its design specifications and conforms to applicable medical device standards, which implies satisfactory performance for its intended use.

Qualitative Acceptance Criteria (Implied by the 510(k) Summary):

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation. The submission relies on non-clinical tests (laboratory and phantom tests) to verify design specifications and compliance with standards.

The data provenance is implied to be from internal laboratory testing conducted by SonoScape Medical Corp. in China. The study is not a retrospective or prospective clinical study on patient data in the typical sense for demonstrating diagnostic accuracy or clinical effectiveness.

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

This information is not provided in the document as there was no clinical testing requiring expert review for ground truth establishment. The document refers to non-clinical laboratory and phantom tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the submission did not involve clinical testing or human reader studies requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No clinical testing was required." (Page 25). Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI assistance is not mentioned or evaluated in this context.

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

This aspect is not applicable as the SonoScape S12 is a diagnostic ultrasound system and does not appear to feature AI algorithms requiring standalone performance evaluation in this 510(k) submission. The document primarily focuses on hardware and core imaging modalities.

7. The Type of Ground Truth Used

For the non-clinical tests (laboratory and phantom tests), the "ground truth" would have been established by:

• Known physical properties of phantoms: For acoustic output, imaging resolution, penetration, etc., phantoms with well-defined characteristics serve as the ground truth.
• Engineering specifications and standards: Compliance with IEC and ISO standards dictates the expected performance and limits.
• Comparison to predicate device's established performance: The primary method for demonstrating safety and effectiveness is substantial equivalence to the predicate device (K142474), implying that the predicate's performance serves as an established baseline.

8. The Sample Size for the Training Set

This information is not applicable as the submission does not describe an AI or machine learning model that would require a "training set." The device is a traditional ultrasound imaging system.

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

This information is not applicable for the same reason as point 8.

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The SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

This SonoScape S12 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 2.0 MHz to 15.0 MHz. This system consists of a mobile console with 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 document describes the safety and performance evaluations for the SonoScape S12 Digital Color Doppler Ultrasound System (K142474) and its transducers, in comparison to predicate devices, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SonoScape S12 Digital Color Doppler Ultrasound System are primarily demonstrated through conformance to established international and national standards, and by showing substantial equivalence to predicate devices for its intended uses and technological characteristics. The document doesn't present a specific table of numerical performance acceptance criteria and reported performance values in a typical AI/software context. Instead, it relies on a comparison of technical specifications and functionalities with predicate devices.

However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicate devices and adherence to standards. Since direct numerical performance metrics are not given, the "Reported Device Performance" for equivalence is qualitative, stating "Same" or "Substantially Equivalent (SE) with detailed analysis".

Here's a summarized view of the comparisons:

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, "Laboratory tests were conducted to verify that the S12 system met all design specifications... Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc."

However, the specific "sample size" for these laboratory and phantom tests (e.g., number of phantom measurements, specific dataset sizes) is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified/mentioned for these tests.

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)

The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on technical specifications, direct comparison to predicate devices, and phantom testing, rather than human expert interpretation of images. The "phantom test" mentioned for Elastography implies a physical standard or controlled environment rather than expert-labeled cases.

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

Since the document does not describe the use of human experts or clinical data for a test set that would require ground truth adjudication, there is no adjudication method mentioned or applicable in the context presented.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. The device is a diagnostic ultrasound system, and the submission focuses on establishing substantial equivalence based on technical characteristics and safety standards, not on AI-assisted diagnostic improvement.

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

The document describes a diagnostic ultrasound system and its transducers, which are hardware devices with embedded software for image acquisition and processing. It is not an AI-based standalone diagnostic algorithm. The phrase "algorithm only without human-in-the-loop performance" is not applicable in this submission. The system produces images for human interpretation.

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

For the Elastography function (the only feature specifically mentioned with a "test"), the ground truth was established using phantom tests. This suggests a physical phantom with known properties (e.g., stiffness) was used as the reference, rather than expert consensus on clinical cases, pathology, or outcomes data. For other aspects of the ultrasound system, the "ground truth" seems to be adherence to engineering specifications and performance matching that of the predicate devices.

8. The sample size for the training set

The document is for a traditional diagnostic ultrasound system and does not mention machine learning or AI algorithms requiring a "training set." Therefore, no training set size is provided or applicable.

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

As there is no mention of a training set (see point 8), the method for establishing its ground truth is also not applicable.

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