Search Results

The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetall OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/ Elastography. The Voluson™ Expert 18, Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided document describes the predicate devices as the Voluson Expert 18, Voluson Expert 20, Voluson Expert 22. The K-number for the primary predicate device is K231965. The document does NOT describe the acceptance criteria or study that proves the device meets the acceptance criteria for those predicate devices. Instead, it details the testing and acceptance criteria for new or updated AI software features introduced with the new Voluson Expert Series devices (K242168).

Here's a breakdown of the requested information based on the AI testing summaries provided for the new/updated features: Sono Pelvic Floor 3.0 (MHD and Anal Sphincter), SonoAVC Follicle 2.0, and 1st/2nd Trimester SonoLyst/SonoLystlive.

Acceptance Criteria and Device Performance for New/Updated AI Features

1. Table of Acceptance Criteria and Reported Device Performance

• On datasets marked as "Good Image Quality": success rate should be 70% or higher.
• On datasets marked as "Challenging Image Quality": success rate should be 60% or higher.
  Overall MHD:
• On "Good IQ" datasets: 70% or higher.
• On "Challenging Quality" datasets: 60% or higher. | MHD Tracking:
• Good Image Quality: 89.3%
• Challenging Image Quality: 77.7%
  Minimum MHD Frame Detection:
• Good Image Quality: 89.3%
• Challenging Image Quality: 83.3%
  Maximum MHD Frame Detection:
• Good Image Quality: 90.66%
• Challenging Image Quality: 77.7%
  Overall MHD:
• On Good IQ datasets: 81.9%
• On Challenging quality datasets: 60.9% |
  | Sono Pelvic Floor 3.0 (Anal Sphincter)| - On datasets marked as "Good Image Quality": success rate should be 70% or higher.
• On datasets marked as "Challenging Image Quality": success rate should be 60% or higher. | The document states "Verification results on actual verification data is as follows" but then the table structure is missing the actual performance metrics for Anal Sphincter. It only lists "On Good IQ datasets: 81.9%" and "On Challenging quality datasets: 60.9%" under the MHD section, implying those might be overall success rates for the entire Sono Pelvic Floor 3.0 feature across both components, but it's not explicitly clear. Therefore, the specific reported device performance for "Anal Sphincter" is not clearly presented in the provided text. |
  | SonoAVC Follicle 2.0 | - The success rate for the AI feature should be 70% or higher. (This appears to be an overall accuracy criterion). | Accuracy:
• On test data acquired together with train cohort: 94.73%
• On test data acquired consecutively post model development: 92.8%
• Overall Accuracy: 93.6%

Dice Coefficient by Size Range:

• 3-5 mm: 0.937619
• 5-10 mm: 0.946289
• 10-15 mm: 0.962315

• 15 mm: 0.93206 |
  | 1st Trimester SonoLyst/SonoLystLive | - The average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy is 80% or higher. | The document states "The average success rate...is 80% or higher" as the acceptance criteria and then mentions "Data used for both training and validation has been collected across multiple geographical sites..." but it does not explicitly provide the numerically reported device performance value that met or exceeded the 80% criterion. |
  | 2nd Trimester SonoLyst/SonoLystLive | - Acceptance criteria are met for both subgroups (variety of ultrasound systems/data formats vs. target platform). (The specific numerical criteria for acceptance are not explicitly stated, but rather that the performance met them for demonstration of generalization.) | The document states "For both subgroups the acceptance criteria are met." but does not explicitly provide the numerically reported device performance values. |

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

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter):

  • Test Set Sample Size: 93 volumes for MHD, 106 volumes for Anal Sphincter.
  • Data Provenance: Data is provided by external clinical partners who de-identified the data. Original data collected in 4D volume Cines (*.vol5 or *.4dv6) or 4D/3D volume acquisitions (*.vol2 or *.4dv3).
  • Countries: A diverse range of countries contributed to the test data including Italy, U.S.A, Australia, Germany, Czech Republic, France, India (for MHD); and Italy, U.S.A, France, Germany, India (for Anal Sphincter).
  • Retrospective/Prospective: The data collection method ("re-process data to our needs retrospectively during scan conversion") suggests a retrospective approach to assembling the dataset, although a "standardized data collection protocol was followed for all acquisitions." New data was also acquired post-model development from previously unseen sites to test robustness.

• SonoAVC Follicle 2.0:

  • Test Set Sample Size: 138 datasets, with a total follicle count of 2708 across all volumes.
  • Data Provenance: External clinical partners provided de-identified data in 3D volumes (*.vol or *.4dv).
  • Countries: Germany, India, Spain, United Kingdom, USA.
  • Retrospective/Prospective: The data was split into train/validation/test at the start of model development (suggesting retrospective). Additionally, consecutive data was acquired post-model development from previously unseen systems and probes to test robustness (suggesting some prospective element for this later test set).

• 2nd Trimester SonoLyst/SonoLystLive:

  • Test Set Sample Size: "Total number of images: 2.2M", "Total number of cine loops: 3595". It's not explicitly stated how much of this was test data vs. training data, but it implies a large dataset for evaluation.
  • Data Provenance: Systems used for data collection included GEHC Voluson V730, E6, E8, E10, Siemens S2000, and Hitachi Aloka. Formats included DICOM & JPEG for still images and RAW data for cine loops.
  • Countries: UK, Austria, India, and USA.
  • Retrospective/Prospective: Not explicitly stated, but "All training data is independent from the test data at a patient level" implies a pre-existing dataset split rather than newly acquired prospective data solely for testing.

• 1st Trimester SonoLyst/SonoLystLive:

  • Test Set Sample Size: SonoLyst 1st Trim IR: 5271 images, SonoLyst 1st Trim X: 2400 images, SonoLyst 1st Trim Live: 6000 images, SonoBiometry CRL: 110 images.
  • Data Provenance: Systems included GE Voluson V730, P8, S6/S8, E6, E8, E10, Expert 22, Philips Epiq 7G. Formats included DICOM & JPEG for still images and RAW data for cine loops.
  • Countries: UK, Austria, India, and USA.
  • Retrospective/Prospective: "All training data is independent from the test data at a patient level." "A statistically significant subset of the test data is independent from the training data at a site level, with no test data collected at the site being used in training." This indicates a retrospective collection with careful splitting, and some test data from unseen sites.

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

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:

  • Number of Experts: Three independent reviewers.
  • Qualifications: "at least two being US Certified sonographers, with extensive clinical experience."

• Additional for 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive:

  • For sorting/grading accuracy review, a "5-sonographer review panel" was used. Qualifications are not specified beyond being sonographers.

4. Adjudication Method for the Test Set

• Sono Pelvic Floor 3.0 (MHD & Anal Sphincter), SonoAVC Follicle 2.0, 2nd Trimester SonoLyst/SonoLystLive, 1st Trimester SonoLyst/SonoLystLive:
  • The evaluation was "based on interpretation of the AI output by reviewing clinicians." The evaluation was "conducted by three independent reviewers."
  • For 2nd and 1st Trimester SonoLyst/SonoLystLive, where sorting/grading accuracy was determined, if initial sorting/grading differed from the ground truth (established by a single sonographer then refined), a 5-sonographer review panel was used, and reclassification was based upon the "majority view of the panel." This implies a form of majority vote adjudication for these specific sub-tasks.
  • The general approach for the three reviewers, especially when evaluating AI output, implies an independent review, and while not explicitly stated, differences would likely lead to discussion or a form of consensus/adjudication. However, a strict 'X+Y' model (like 2+1 or 3+1) is not explicitly detailed.

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

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to measure how human readers improve with AI vs. without AI assistance. The studies described are primarily aimed at assessing the standalone performance or workflow utility of the AI features.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, standalone performance was assessed for all described AI features. The "Summary test Statistics" and "Verification Results" sections for each feature (Sono Pelvic Floor 3.0, SonoAVC Follicle 2.0, 1st/2nd Trimester SonoLyst/SonoLystLive) report the algorithm's direct performance (e.g., success rates, accuracy, Dice coefficient) against the established ground truth, indicating standalone evaluation. The "interpretation of the AI output by reviewing clinicians" method primarily focuses on validating the AI's direct result rather than a comparative human performance study.

7. The Type of Ground Truth Used

• Expert Consensus/Annotation:
  • Sono Pelvic Floor 3.0 (MHD): Ground truth was established through a "two-stage curation process." Curators identified the MHD plane and marked anatomical structures. These curated datasets were then "reviewed by expert arbitrators."
  • Sono Pelvic Floor 3.0 (Anal Sphincter): Ground truth involved "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Each volume was "reviewed by a skilled arbitrator for correctness."
  • SonoAVC Follicle 2.0: The "Truthing process for training dataset" indicates a "detailed curation protocol (developed by clinical experts)" and a "two-step approach" with an arbitrator reviewing all datasets for clinical accuracy.
  • 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: Ground truth for sorting/grading was initially done by a single sonographer, then reviewed by a "5-sonographer review panel" for accuracy, with reclassification based on majority view if needed.

8. The Sample Size for the Training Set

• Sono Pelvic Floor 3.0 (MHD): Total Volumes: 983
• Sono Pelvic Floor 3.0 (Anal Sphincter): Total Volumes: 828
• SonoAVC Follicle 2.0: Total Volumes: 249
• 2nd Trimester SonoLyst/SonoLystLive: "Total number of images: 2.2M", "Total number of cine loops: 3595". (The precise breakdown of training vs. test from this total isn't given for this feature, but it's a large overall dataset).
• 1st Trimester SonoLyst/SonoLystLive: 122,711 labelled source images from 35,861 patients.

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

• Sono Pelvic Floor 3.0 (MHD): A two-stage curation process. First, curators identify the MHD plane and then mark anatomical structures. These curated datasets are then reviewed by expert arbitrators and "changes/edits made if necessary to maintain correctness and consistency in curations."
• Sono Pelvic Floor 3.0 (Anal Sphincter): "3D segmentation of the Anal Canal using VOCAL tool in the 4D View5 Software." Curation protocol involved aligning the volume and segmenting the Anal Canal. Each volume was "reviewed by a skilled arbitrator for correctness."
• SonoAVC Follicle 2.0: A "two-step approach" was followed. First, curators were trained on a "detailed curation protocol (developed by clinical experts)." Second, an automated quality control step confirmed mask/marking availability, and an arbitrator reviewed all datasets from each curator's completed data pool for clinical accuracy, with inconsistencies discussed by the curation team.
• 2nd Trimester SonoLyst/SonoLystLive & 1st Trimester SonoLyst/SonoLystLive: The images were initially "curated (sorted and graded) by a single sonographer." If these differed from the ground truth (which implies a higher standard or previous ground truth for comparison), a "5-sonographer review panel" reviewed them and reclassified based on majority view to achieve the final ground truth.

Ask a specific question about this device

The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Here's an analysis of the acceptance criteria and supporting studies for the device, based on the provided text:

Acceptance Criteria and Device Performance

The document describes several AI features: SonoAVC2.0, SonoPelvicFloor2.0, Fibroid Mapping, and SonoLyst/SonoLyst Live.

SonoAVC2.0 is explicitly stated to have migrated from a previously cleared device (K230346, Voluson SWIFT/SWIFT+) as "Auto Caliper," implying its performance has already met acceptance criteria in that context. No new specific acceptance criteria or performance metrics are provided for SonoAVC2.0 in this document.

SonoPelvicFloor2.0

Fibroid Mapping

Fibroid Mapping (Quantitative Evaluation - DICE Scores when successful)

SonoLyst/SonoLyst Live (2nd Trimester Features)

Study Details

SonoPelvicFloor2.0

1. Sample Size and Data Provenance (Test Set):

   • Total Volumes: 94
   • Distribution by Systems: Voluson Expert 22 (82), Voluson E8 (8), Voluson E6 (4)
   • Distribution by Probes: RAB6-D (41), RIC5-9-D (21), RM7C (32)
   • Distribution by Countries: Austria (36), U.S.A (47), South Africa (4), Czech Republic (7)
   • Data Provenance: Retrospective. Data is "provided by external clinical partners who de-identified the data before sharing it with us." Original data is collected in the form of 4D volume Cines, preserving flexibility for retrospective re-processing. The data covers multiple geographical sites.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • The verification was "performed by clinical experts" and involved an "internal clinical expert" for assessment.
   • Specific numbers or qualifications (e.g., years of experience, specialty) of these experts are not explicitly stated in the provided text.

3. Adjudication Method (Test Set):

   • Not explicitly described as a formal adjudication method (e.g., 2+1). The "internal clinical expert" documents the assessment.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for this feature. Performance is reported as standalone accuracy.

5. Standalone Performance:

   • Yes, the reported accuracy (96% on good IQ, 93% on challenging IQ) is for the algorithm's standalone performance.

6. Type of Ground Truth:

   • "Internal clinical expert" assessment based on a specific workflow (observing automated placement of MHD plane and assessing success/failure). This would constitute expert consensus/judgment on the algorithm's output.

7. Sample Size for Training Set:

   • Volumes: 983 distinct volumes
   • Patients: 616 individual patients
   • Images (generated): 8847 images (3 slices from each volume with three rotation angles per image)
   • Distribution by Systems: V730 (116), Voluson E10 (482), Voluson E6 (21), Voluson E8 (90), Voluson P8 (274)
   • Distribution by Probes: RAB 4-8L (116), RAB2-6-RS (38), RAB6-D (111), RIC5-9A-RS (236), RIC5-9-D (8), RM6C (474)
   • Distribution by Countries: Australia (116), Austria (8), Belgium (465), Czech Republic (100), Japan (236), Italy (37), South Africa (21)

8. How Ground Truth for Training Set was Established:

   • Not explicitly detailed for the training set within the provided text. However, it states that "Data used for both training and validation has been collected across multiple geographical sites" and "Data is provided by external clinical partners who de-identified the data." This implies that clinical experts or medical professionals initially generated the data, which was then de-identified. The process of labeling or establishing "ground truth" (e.g., manual annotations of pelvic floor structures) on these 983 volumes for training is not described.

Fibroid Mapping

1. Sample Size and Data Provenance (Test Set/Verification):

   • Primary Verification:
     • Total Volumes: 78
     • Systems: Voluson Expert Series
     • Probes: RIC5-9-D, RIC6-12-D
     • Countries: Egypt, Greece, Korea, Philippines, Romania, USA.
   • Secondary Evaluation (Qualitative and Quantitative):
     • Total Volumes: 74
     • Systems: Voluson Expert Series
     • Probes: RIC5-9-D, RIC10-D
     • Countries: Austria, Egypt, Germany, Greece, Korea, Philippines, Romania, USA.
   • Data Provenance: Retrospective. Data "provided by external clinical partners who de-identified the data before sharing it with us." Original data is collected in 3D/4D volumes.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • Verification "performed by clinical experts."
   • "Independent clinical experts" for qualitative assessment and correlation with DICE scores.
   • "Internal and external clinical experts" were consulted for defining requirements for success rates.
   • Specific numbers or qualifications (e.g., years of experience, specialty) of these experts are not explicitly stated in the provided text.

3. Adjudication Method (Test Set):

   • Not explicitly described as a formal adjudication method. Clinical experts perform the qualitative assessment and judge if segmentation is "satisfying." If not, they may return to an earlier step or activate manual segmentation.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for this feature. Performance is reported as a standalone success rate and DICE scores.

5. Standalone Performance:

   • Yes, the reported success rates and DICE scores are for the algorithm's standalone performance in segmentation.

6. Type of Ground Truth:

   • Qualitative: "Clinical expert" assessment of whether the segmentation is "satisfying."
   • Quantitative: DICE scores calculated against what is presumably expert-annotated ground truth segmentations, which are then correlated with the qualitative expert assessment. The explicit method for defining this precise quantitative ground truth (e.g., expert manual segmentation per pixel) is not detailed for the test set.

7. Sample Size for Training Set:

   • Unique Volumes: 779
   • Augmented Volumes: 7790

8. How Ground Truth for Training Set was Established:

   • "We collected training data of the following types from hospital centers as well as private practices. We provided a dedicated data collection protocol explaining the required data needs to each provider." This implies a structured collection, but the actual process of defining the ground truth for segmentation (e.g., manual outlining of fibroids, uterus, endometrium by experts on each training image) is not explicitly described.

SonoLyst/SonoLyst Live (2nd Trimester Features) Improvement

1. Sample Size and Data Provenance (Test Set):

   • Quantitative Evaluation for SonoLyst 2nd Trimester IR: 42102 images
   • Quantitative Evaluation for SonoLyst 2nd Trimester X: 10424 images
   • Quantitative Evaluation for SonoLystLive 2nd Trimester: 5666 images
   • Data Provenance: Retrospective. Data collected from routine clinical practice in hospitals and private practice during mid-trimester examinations. Countries include UK, Austria, India, and USA.

2. Number and Qualifications of Experts for Ground Truth (Test Set):

   • Sonographer Panel: 5 sonographers were used to review sorted and graded images for accuracy.
   • Initial Curation: A "single sonographer" initially curated (sorted and graded) the images.
   • Specific qualifications (e.g., years of experience) for these sonographers are not explicitly stated.

3. Adjudication Method (Test Set):

   • Majority View: For images where the initial sonographer's sorting differed from the algorithm's initial classification, a 5-sonographer review panel determined the sorting accuracy, resulting in reclassification based on the "majority view of the panel."
   • For graded images, the 5-sonographer panel reviewed where they differed from the initial ground truth to determine grading accuracy. This is a form of 5-reader consensus/adjudication.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • The verification of SonoLystLive 2nd Trimester features is based on "the average agreement between a sonographer panel and the output of the algorithm regarding Traffic light quality." While this involves multiple readers assessing the algorithm's output, it's described more as a validation of the algorithm's performance against human judgment rather than a comparative effectiveness study showing human reader improvement with AI assistance. No effect size of human improvement with AI vs. without is provided.

5. Standalone Performance:

   • Yes, the reported average success rate of 80% or higher for SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is a standalone measure of the algorithm's performance in sorting and grading.

6. Type of Ground Truth:

   • Expert Consensus: A "sonographer review panel" (5 sonographers) provided the ground truth for both sorting and grading accuracy, based on a majority view where discrepancies arose with an initial sonographer's assessment.

7. Sample Size for Training Set:

   • Total Images: 2.2 million
   • Total Cine Loops: 2570
   • Data collected across multiple geographical sites using different systems (GE Voluson V730, E6, E8, E10, Siemens Acuson S2000 and Hitachi Aloka).

8. How Ground Truth for Training Set was Established:

   • Not explicitly described for the training set in this section. General statement that "Data used for both training and validation has been collected across multiple geographical sites." The detailed "truthing process" mentioned focuses on the verification data, not the much larger training set. It's common for training data to be annotated by experts, but the specifics are not provided here.

Ask a specific question about this device

The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Here's a breakdown of the acceptance criteria and study details for the AI features of the Voluson Expert Series, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details for AI Features

1. SonoPelvic Floor:

• Sample size for the test set: 110 3D/4D Volumes from 70+ individual patients.
• Data provenance: Images collected from Europe, Asia, and South Africa.
• Number of experts used to establish ground truth & qualifications: The results generated by the AI software were verified as "Pass or Fail" by a "certified sonographer/Clinician." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographer/Clinician" are not detailed.
• Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or a specific consensus method beyond single expert review.
• MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
• Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in generating results.
• Type of ground truth used: Expert verification by a "certified sonographer/Clinician."
• Sample size for the training set: Not specified, but it's stated that the volumes used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
• How the ground truth for the training set was established: Not specified.

2. SonoLyst:

• Sample size for the test set: 40,000+ images derived from 5,000+ exams (individual patients).
• Data provenance: Exams from the United Kingdom, Austria, India, USA. A mix of retrospective and prospective data collection from GE and non-GE scanners.
• Number of experts used to establish ground truth & qualifications:
  • Initial curation (sorting and grading) by a "single Sonographer."
  • Review panel of "5-sonographer[s]" for instances where SonoLyst differed from the initial ground truth, to determine sorting and grading accuracy. Qualifications beyond "sonographer" are not detailed.
• Adjudication method:
  • Initial ground truth established by a single sonographer.
  • Discrepancies between the AI and initial ground truth were reviewed by a "5-sonographer review panel." The sorting ground truth was reclassified based on the "majority view of the panel." This implies a form of 5-sonographer consensus, where the majority dictates the revised ground truth.
• MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
• Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in sorting and grading images.
• Type of ground truth used: Expert consensus, specifically from a panel of 5 sonographers for ambiguous cases, following initial assessment by a single sonographer.
• Sample size for the training set: Not specified, but it's stated that the exams used for testing were "separated from the ones used during training process and there is no overlap between the two."
• How the ground truth for the training set was established: Not specified.

3. FetalHS:

• Sample size for the test set: 400+ cines from 250+ patients.
• Data provenance: USA, India, Japan, Germany, Austria.
• Number of experts used to establish ground truth & qualifications: The AI software's results were verified as "Pass or Fail" by "certified sonographers/clinicians." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographers/clinicians" are not detailed.
• Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or specific consensus beyond single expert review.
• MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
• Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in suggesting views and measuring heart angles.
• Type of ground truth used: Expert verification by "certified sonographers/clinicians."
• Sample size for the training set: Not specified, but it's stated that the datasets used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
• How the ground truth for the training set was established: Not specified.

Ask a specific question about this device