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The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by appropriately trained healthcare professionals in hospital for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vasculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape P60 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 phased array and etc.

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, Direct Power Doppler, or the combination of these modes, Compound, 3D/4D, Elastography and Contrast.

Here's a breakdown of the acceptance criteria and the study details for the S-FetusAI feature of the Sonoscape Digital Color Doppler Ultrasound System (P60 Series), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance:

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

• S-Fetus-Recognition Test Set:
  • More than 200 images for each of the 14 standard sections.
  • Total: 3717 images.
• S-Fetus-Measure Test Set:
  • More than 250 images for each of the 9 standard sections.
  • Total: 2929 images.
• Data Provenance: A mix of retrospective and prospective data collection in clinical practice. The test sets were collected at three hospitals in China.

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

• Initial Ground Truth Drawing: Five OB/GYN experts with more than 3 years' experience.
• Cross-checking: Two experts with more than 20 years' experience.
• Re-checking: Four experts with more than 30 years' experience.
• Clinical Performance Study (Adjudication of results): Two Readers from an independent evaluation group, consisting of qualified professionals (senior experts who had been involved in prenatal ultrasound examination).

4. Adjudication Method for the Test Set

The ground truth was established through a multi-level expert consensus process:

1. Initial Drawing: 5 OB/GYN experts.
2. Cross-checking: 2 senior experts.
3. Re-checking: 4 very senior experts.
   This indicates a robust, multi-stage consensus-based adjudication, effectively a form of "expert consensus with multiple layers of review."

For the clinical performance testing, a separate "independent evaluation group" with 2 senior experts evaluated the section recognition results and precision of Sp from both the trial (AI-assisted) and contrast (manual) groups.

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

• A clinical performance testing was conducted, which involved comparing the S-FetusAI function (Trial group) with manual recognition and measurement by investigators (Contrast group). This can be considered a comparative effectiveness study.
• Research Group Composition (Contrast Group): Investigators (physicians with more than 3 years of specialized training in obstetric ultrasound examination; total 7 investigators) performing manual recognition and measurement.
• Effect Size: The study focused on demonstrating non-inferiority rather than a specific improvement percentage for human readers with AI assistance. The conclusion states that "the recognition precision of the standard sections of S-FetusAI was not inferior to that of the manual scan." This implies that the AI-assisted system performs at least as well as, or comparably to, manual recognition. It does not explicitly quantify how much human readers improve when using AI, but rather that the AI's standalone performance (for recognition) and consistency/precision (for measurement) are comparable to manual methods.

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

Yes, a standalone performance testing was done for the S-FetusAI feature for both S-Fetus-Recognition and S-Fetus-Measure. The results (90.01% accuracy for recognition and 85% accuracy for measurement) are reported as entirely algorithmic performance against established ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus. It was established by multiple OB/GYN experts with varying levels of experience, going through a process of initial drawing, cross-checking, and re-checking. Any images not meeting inclusion/exclusion criteria were excluded from the ground truth set.

8. The Sample Size for the Training Set

The document explicitly states: "The test set used to test the standalone performance of S-FetusAI are independent of the training data set and tuning data set". However, the sample size for the training set is not provided in the given text.

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

While the document implies that training and tuning datasets were used, the specific method for establishing their ground truth is not mentioned in the provided text. It only details the ground truth establishment for the test set.

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The SonoScape S40 device 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S40 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

This document describes the SonoScape S40 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S6). The information provided is primarily for regulatory submission and does not detail a clinical study with an acceptance criterion for device performance in the way a clinical trial for an AI algorithm would. Instead, it focuses on technical specifications and compliance with safety standards to demonstrate substantial equivalence.

Based on the provided text, a "study" in the sense of a clinical performance study with human readers or standalone algorithm performance, as typically found in AI/ML device submissions, was not conducted. The study supporting this device's acceptance is a bench testing and comparison study against a predicate device and relevant safety standards.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the performance characteristics of the predicate device (SonoScape S6) and compliance with international safety and performance standards. The "reported device performance" is the comparison of the SonoScape S40 against the S6.

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

• Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study on patients. The testing involved laboratory testing to verify design specifications and compliance with standards. It's implied that various transducers were tested for their acoustic output and safety characteristics.
• Data Provenance: The testing was conducted internally by SonoScape Company Limited ("Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification..."). The country of origin for the data would be China, where SonoScape is based.
• Retrospective or Prospective: This was likely prospective bench testing and engineering validation against predefined specifications and standards, rather than retrospective or prospective clinical data collection from patients.

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

• This type of information is not provided in the 510(k) summary. The submission does not describe a clinical study requiring human expert ground truth for interpretation of images. The ground truth for the technical measurements and safety compliance would be established by validated test equipment and calibration standards, assessed by qualified engineers and technicians, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. Given that no clinical test with human experts interpreting results was conducted, an adjudication method like 2+1 or 3+1 is not relevant to this submission.

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

• No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "No clinical testing was required." (Section 8). The comparison was primarily technical specifications against a predicate device.

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

• Not applicable / No. This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation. Its performance is evaluated based on its ability to acquire and display ultrasound data accurately and safely, matching or improving upon the predicate device's technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the acceptance of this device relies on:
  • Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed SonoScape S6 ultrasound system.
  • International Safety and Performance Standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-5, and ISO 10993-10.
  • Bench Test Results: Direct measurements of technical parameters (e.g., measurement accuracy for distance, area, velocity, acoustic output) using calibrated equipment.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware and software system, not an AI/ML algorithm that is "trained" on a specific dataset. Its development involves standard engineering design, testing, and validation processes.

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

• Not applicable. As there is no "training set" in the AI/ML sense, there is no ground truth established for one. The device's functionality is based on established ultrasound physics and engineering principles.

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The SonoScape S11 device 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S11 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

The provided 510(k) summary is for a diagnostic ultrasound system, which is a hardware device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized safety standards, rather than clinical performance metrics often associated with AI/ML-enabled devices.

Therefore, many of the requested criteria (acceptance criteria related to clinical performance, specific study types like MRMC, sample sizes for test/training sets, ground truth establishment, or expert qualifications) are not applicable or detailed in this document. The submission asserts substantial equivalence based on comparisons of design, function, and safety characteristics with a predicate device.

Here's a breakdown of what can be extracted and what is not provided based on the input:

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

The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity, as it's an ultrasound hardware device submission focused on substantial equivalence rather than a new clinical claim. Its "performance" is implicitly deemed acceptable if it meets the technical specifications and safety standards, and is substantially equivalent to the predicate.

The table below summarizes the comparison items where "SE" (Substantially Equivalent) is indicated, implying the proposed device meets the predicate's performance in those aspects.

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 explicitly states "No clinical testing was required." Therefore, there is no information on sample size for a test set or data provenance related to clinical data. The testing mentioned in Section 7 refers to "Laboratory testing" to verify design specifications and compliance with safety standards, which is not a clinical test set.

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 or test set requiring ground truth was conducted for this submission.

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

Not applicable, as no clinical testing or test set requiring adjudication was conducted for this 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

Not applicable. This device is a diagnostic ultrasound system, not an AI-enabled device designed to assist human readers. No MRMC study was mentioned.

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

Not applicable. This is a hardware device; it does not perform as a standalone algorithm in the sense of AI/ML.

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

Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of AI/ML algorithms.

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

Not applicable, as there is no training set for this hardware device.

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