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    K Number
    K251985
    Device Name
    LOGIQ E10
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Cleared
    2025-10-29

    (124 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K232381,K201768,K220882,K183575
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232381, K201768, K220882, K183575

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic, Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Tranesophageal and Intraoperative (Abdominal and Vascular).

    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, Attenuation Imaging and combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

    The LOGIQ E10 is intended to be used in a hospital or medical clinic.

    Device Description

    The LOGIQ E10 is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting studies for the LOGIQ E10 ultrasound system, derived from the provided FDA 510(k) Clearance Letter:

    1. Table of Acceptance Criteria and Reported Device Performance

    Feature/MetricAcceptance CriteriaReported Device Performance
    Auto Abdominal Color Assistant 2.0
    Overall Model Detection Accuracy$\ge 80%$$94.8%$
    Sensitivity (True Positive Rate)$\ge 80%$$0.91$
    Specificity (True Negative Rate)$\ge 80%$$0.98$
    DICE Similarity Coefficient (Segmentation Accuracy)$\ge 0.80$$0.82$
    Auto Aorta Measure Assistant (Long View AP Measurement)
    Average AccuracyNot explicitly stated as a target percentage, but implied by strong performance metrics$87.2%$ (95% CI of $\pm 1.98%$)
    Average Absolute ErrorNot explicitly stated as a target$0.253$ cm (95% CI of $0.049$ cm)
    Limits of AgreementNot explicitly stated as a target range$(-0.15, 0.60)$ cm (95% CI of $(-0.26, 0.71)$)
    Auto Aorta Measure Assistant (Short View AP Measurement)
    Average AccuracyNot explicitly stated as a target percentage, but implied by strong performance metrics$92.9%$ (95% CI of $\pm 2.02%$)
    Average Absolute ErrorNot explicitly stated as a target$0.128$ cm (95% CI of $0.037$ cm)
    Limits of AgreementNot explicitly stated as a target range$(-0.21, 0.36)$ cm (95% CI of $(-0.29, 0.45)$)
    Auto Aorta Measure Assistant (Short View Trans Measurement)
    Average AccuracyNot explicitly stated as a target percentage, but implied by strong performance metrics$86.9%$ (95% CI of $\pm 6.25%$)
    Average Absolute ErrorNot explicitly stated as a target$0.235$ cm (95% CI of $0.110$ cm)
    Limits of AgreementNot explicitly stated as a target range$(-0.86, 0.69)$ cm (95% CI of $(-1.06, 0.92)$)
    Auto Common Bile Duct (CBD) Measure Assistant (Porta Hepatis measurement accuracy without segmentation scroll edit)
    Average AccuracyNot explicitly stated as a target percentage, but implied by strong performance metrics$59.85%$ (95% CI of $\pm 17.86%$)
    Average Absolute ErrorNot explicitly stated as a target$1.66$ mm (95% CI of $1.02$ mm)
    Limits of AgreementNot explicitly stated as a target range$(-4.75, 4.37)$ mm (95% CI of $(-6.17, 5.79)$)
    Auto Common Bile Duct (CBD) Measure Assistant (Porta Hepatis measurement accuracy with segmentation scroll edit)
    Average AccuracyNot explicitly stated as a target percentage, but implied by strong performance metrics$80.56%$ (95% CI of $\pm 8.83%$)
    Average Absolute ErrorNot explicitly stated as a target$0.91$ mm (95% CI of $0.45$ mm)
    Limits of AgreementNot explicitly stated as a target range$(-1.96, 3.25)$ mm (95% CI of $(-2.85, 4.14)$)
    Ultrasound Guided Fat Fraction (UGFF)
    Correlation Coefficient with MRI-PDFF (Japan Cohort)Strong correlation confirmed$0.87$
    Offset (UGFF vs MRI-PDFF, Japan Cohort)Not explicitly stated as a target$-0.32%$
    Limits of Agreement (UGFF vs MRI-PDFF, Japan Cohort)Not explicitly stated as a target range$-6.0%$ to $5.4%$
    % Patients within $\pm 8.4%$ difference (Japan Cohort)Not explicitly stated as a target$91.6%$
    Correlation Coefficient with MRI-PDFF (US/EU Cohort)Strong correlation confirmed$0.90$
    Offset (UGFF vs MRI-PDFF, US/EU Cohort)Not explicitly stated as a target$-0.1%$
    Limits of Agreement (UGFF vs MRI-PDFF, US/EU Cohort)Not explicitly stated as a target range$-3.6%$ to $3.4%$
    % Patients within $\pm 4.6%$ difference (US/EU Cohort)Not explicitly stated as a target$95.0%$
    Correlation Coefficient with UDFF (EU Cohort)Strong correlation confirmed$0.88$
    Offset (UGFF vs UDFF, EU Cohort)Not explicitly stated as a target$-1.2%$
    Limits of Agreement (UGFF vs UDFF, EU Cohort)Not explicitly stated as a target range$-5.0%$ to $2.6%$
    % Patients within $\pm 4.7%$ difference (EU Cohort)Not explicitly stated as a targetAll patients

    2. Sample Size for Test Set and Data Provenance

    • Auto Abdominal Color Assistant 2.0:
      • Test Set Sample Size: 49 individual subjects, 1186 annotation images.
      • Data Provenance: Retrospective, all data from the USA.
    • Auto Aorta Measure Assistant:
      • Test Set Sample Size:
        • Long View Aorta: 36 subjects (11 Male, 25 Female).
        • Short View Aorta: 35 subjects (11 Male, 24 Female).
      • Data Provenance: Retrospective, from Japan (15-16 subjects) and USA (20 subjects).
    • Auto Common Bile Duct (CBD) Measure Assistant:
      • Test Set Sample Size: 25 subjects (11 Male, 14 Female).
      • Data Provenance: Retrospective, from USA (40%) and Japan (60%).
    • Ultrasound Guided Fat Fraction (UGFF):
      • Test Set Sample Size (Primary Study): 582 participants.
      • Data Provenance (Primary Study): Retrospective, Japan.
      • Test Set Sample Size (Confirmatory Study 1): 15 US patients + 5 EU patients (total 20).
      • Data Provenance (Confirmatory Study 1): Retrospective, USA and EU.
      • Test Set Sample Size (Confirmatory Study 2): 24 EU patients.
      • Data Provenance (Confirmatory Study 2): Retrospective, EU.

    3. Number of Experts and Qualifications for Ground Truth

    • Auto Abdominal Color Assistant 2.0: Not explicitly stated, but implies multiple "readers" to ground truth anatomical visibility. No specific qualifications are mentioned beyond "readers."
    • Auto Aorta Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
    • Auto Common Bile Duct (CBD) Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
    • Ultrasound Guided Fat Fraction (UGFF): Ground truth for the primary study was MRI Proton Density Fat Fraction (MRI-PDFF %). No human experts were involved in establishing the ground truth for UGFF, as it relies on MRI-PDFF as the reference. The correlation between UGFF and UDFF also used UDFF as a reference, not human experts.

    4. Adjudication Method for the Test Set

    • Auto Abdominal Color Assistant 2.0: Not explicitly mentioned, however, the process described as "Readers to ground truth the 'anatomy' visible in static B-Mode image. (Before running AI)" and then comparing to AI predictions does not suggest an adjudication process for the ground truth generation itself beyond initial reader input. Confusion matrices were generated later.
    • Auto Aorta Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
    • Auto Common Bile Duct (CBD) Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
    • Ultrasound Guided Fat Fraction (UGFF): Ground truth was established by MRI-PDFF or comparison to UDFF. No human adjudication method was described for these.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Auto Aorta Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
      • Effect Size:
        • Long View Aorta AP Measurement: Average reduction from $4.132 \pm 0.291$ keystrokes (without AI) to $1.236 \pm 0.340$ keystrokes (with AI).
        • Short View Aorta AP and Trans Measurement: Average reduction from $7.05 \pm 0.158$ keystrokes (without AI) to $2.307 \pm 1.0678$ keystrokes (with AI).
    • Auto Common Bile Duct (CBD) Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
      • Effect Size: Average reduction of $1.62 \pm 0.375$ keystrokes (mean and standard deviation) from manual to AI-assisted measurements.
    • Other features (Auto Abdominal Color Assistant 2.0, UGFF): The documentation does not describe a MRMC study for improved human reader performance with AI assistance for these features.

    6. Standalone (Algorithm Only) Performance Study

    • Auto Abdominal Color Assistant 2.0: Yes, the model's accuracy (detection accuracy, sensitivity, specificity, DICE score) was evaluated in a standalone manner against the human-annotated ground truth.
    • Ultrasound Guided Fat Fraction (UGFF): Yes, the correlation and agreement of the UGFF algorithm's values were tested directly against an established reference standard (MRI-PDFF) and another device's derived fat fraction (UDFF).

    7. Type of Ground Truth Used

    • Auto Abdominal Color Assistant 2.0: Expert consensus/annotations on B-Mode images, followed by comparison to AI predictions.
    • Auto Aorta Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
    • Auto Common Bile Duct (CBD) Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
    • Ultrasound Guided Fat Fraction (UGFF): Established clinical reference standard: MRI Proton Density Fat Fraction (MRI-PDFF %). For one confirmatory study, another cleared device's derived fat fraction (UDFF) was used as a comparative reference.

    8. Sample Size for the Training Set

    • The document states that "The exams used for test/training validation purpose are separated from the ones used during training process" but does not provide the sample size for the training set itself for any of the AI features.

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

    • The document implies that the ground truth for training data would have been established similarly to the test data ground truth (e.g., expert annotation for Auto Abdominal Color Assistant, expert measurements for Auto Aorta/CBD Measure Assistants). However, the specific methodology for the training set's ground truth establishment (e.g., number of experts, adjudication, qualifications) is not detailed in the provided text. It only explicitly states that "Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images" for annotation. Independence of test and training data by exam site origin or overall separation is mentioned, but not the process for creating the training set ground truth.
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    K Number
    K251963
    Device Name
    LOGIQ E10s
    Manufacturer
    GE Medical Systems Ultrasound and Primary care Diagnostics,
    Date Cleared
    2025-10-29

    (125 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K232381,K231301,K201768,K220882,K183575,K231989
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232381, K231301, K201768, K220882, K183575

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LOGIQ E10s is intended for use by a qualified physician for ultrasound evaluation.

    Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology / Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

    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, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

    The LOGIQ E10s is intended to be used in a hospital or medical clinic.

    Device Description

    The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

    AI/ML Overview

    The provided text describes three AI features: Auto Abdominal Color Assistant 2.0, Auto Aorta Measure Assistant, and Auto Common Bile Duct (CBD) Measure Assistant, along with a UGFF Clinical Study.

    Here's an analysis of the acceptance criteria and study details for each, where available:

    1. Table of Acceptance Criteria and Reported Device Performance

    For Auto Abdominal Color Assistant 2.0

    Acceptance CriteriaReported Device PerformanceMeets Criteria?
    Overall model detection accuracy (sensitivity and specificity): $\ge 80%$ (0.80)Accuracy: 94.8%Yes
    Sensitivity (True Positive Rate): $\ge 80%$ (0.80)Sensitivity: 0.91Yes
    Specificity (True Negative Rate): $\ge 80%$ (0.80)Specificity: 0.98Yes
    DICE Similarity Coefficient (Segmentation Accuracy): $\ge 0.80$DICE score: 0.82Yes

    For Auto Aorta Measure Assistant

    Acceptance CriteriaReported Device PerformanceMeets Criteria?
    No explicit numerical acceptance criteria were provided for keystrokes or measurement accuracy. The study aims to demonstrate improvement in keystrokes and acceptable accuracy. The provided results are the performance reported without specific targets for acceptance.Long View Aorta:- Average keystrokes: 4.132 (without AI) vs. 1.236 (with AI)- Average accuracy: 87.2% with 95% CI of +/- 1.98%- Average absolute error: 0.253 cm with 95% CI of 0.049 cm- Limits of Agreement: (-0.15, 0.60) with 95% CI of (-0.26, 0.71)Short View AP Measurement:- Average accuracy: 92.9% with 95% CI of +/- 2.02%- Average absolute error: 0.128 cm with 95% CI of 0.037 cm- Limits of Agreement: (-0.21, 0.36) with 95% CI of (-0.29, 0.45)Short View Trans Measurement:- Average accuracy: 86.9% with 95% CI of +/- 6.25%- Average absolute error: 0.235 cm with 95% CI of 0.110 cm- Limits of Agreement: (-0.86, 0.69) with 95% CI (-1.06, 0.92)N/A

    For Auto Common Bile Duct (CBD) Measure Assistant

    Acceptance CriteriaReported Device PerformanceMeets Criteria?
    No explicit numerical acceptance criteria were provided for keystrokes or measurement accuracy. The study aims to demonstrate reduction in keystrokes and acceptable accuracy. The provided results are the performance reported without specific targets for acceptance.- Average reduction in keystrokes (manual vs. AI): 1.62 +/- 0.375Keystrokes for Porta Hepatis measurement with segmentation scroll edit- Average accuracy: 80.56% with 95% CI of +/- 8.83%- Average absolute error: 0.91 mm with 95% CI of 0.45 mm- Limits of Agreement: (-1.96, 3.25) with 95% CI of (-2.85, 4.14)Porta Hepatis measurement accuracy without segmentation scroll edit- Average accuracy: 59.85% with 95% CI of +/- 17.86%- Average absolute error: 1.66 mm with 95% CI of 1.02 mm- Limits of Agreement: (-4.75, 4.37) with 95% CI of (-6.17, 5.79)N/A

    For UGFF Clinical Study

    Acceptance Criteria (Implied by intent to demonstrate strong correlation)Reported Device PerformanceMeets Criteria?
    Strong correlation between UFF values and MRI-PDFF (e.g., correlation coefficient $\ge 0.8$)Original study: Correlation coefficient = 0.87Confirmatory study (US/EU): Correlation coefficient = 0.90(Confirmatory study (UGFF vs UDFF): Correlation coefficient = 0.88)Yes
    Acceptable Limits of Agreement with MRI-PDFF (e.g., small offset and LOA with high percentage of patients within LOA)Original study: Offset = -0.32%, LOA = -6.0% to 5.4%, 91.6% patients within LOAConfirmatory study (US/EU): Offset = -0.1%, LOA = -3.6% to 3.4%, 95.0% patients within LOAYes
    No statistically significant effect of BMI, SCD, and other demographic confounders on AC, BSC, and SNR measurements (Implied)The results of the clinical study indicate that BMI, SCD, and other demographic confounders do not have a statistically significant effect on measurements of the AC, BSC, and SNR.Yes

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

    Auto Abdominal Color Assistant 2.0:

    • Sample Size: 49 individual subjects (1186 annotation images)
    • Data Provenance: Retrospective, from the USA (100%).

    Auto Aorta Measure Assistant:

    • Sample Size:
      • Long View Aorta: 36 subjects
      • Short View Aorta: 35 subjects
    • Data Provenance: Retrospective, from Japan and USA.

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Sample Size: 25 subjects
    • Data Provenance: Retrospective, from USA (40%) and Japan (60%).

    UGFF Clinical Study:

    • Sample Size:
      • Original study: 582 participants
      • Confirmatory study (US/EU): 15 US patients and 5 EU patients (total 20)
      • Confirmatory study (UGFF vs UDFF): 24 EU patients
    • Data Provenance: Retrospective and Prospective implicitly (clinical study implies data collection).
      • Original Study: Japan (Asian population)
      • Confirmatory Study (US/EU): US and EU (demographic info unavailable for EU patients, US patients: BMI 21.0-37.5, SCD 13.9-26.9)
      • Confirmatory Study (UGFF vs UDFF): EU

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

    Auto Abdominal Color Assistant 2.0:

    • Number of Experts: Not specified. The text mentions "Readers to ground truth the 'anatomy'".
    • Qualifications of Experts: Not specified.

    Auto Aorta Measure Assistant:

    • Number of Experts: Not specified. The text mentions "Readers to ground truth the AP measurement..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
    • Qualifications of Experts: Not specified.

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Number of Experts: Not specified. The text mentions "Readers to ground truth the diameter..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
    • Qualifications of Experts: Not specified.

    UGFF Clinical Study:

    • Number of Experts: Not applicable, as ground truth was established by MRI-PDFF measurements, not expert consensus on images.

    4. Adjudication method for the test set

    Auto Abdominal Color Assistant 2.0:

    • Adjudication Method: Not explicitly described as a specific method (e.g., 2+1). The process mentions "Readers to ground truth" and then comparison to AI predictions, but no specific adjudication among multiple readers' initial ground truths.

    Auto Aorta Measure Assistant:

    • Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." This suggests multiple readers provide measurements, and a single arbitrator makes the final ground truth selection.

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." Similar to the Aorta assistant.

    UGFF Clinical Study:

    • Adjudication Method: Not applicable. Ground truth was established by MRI-PDFF measurements.

    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

    Auto Abdominal Color Assistant 2.0:

    • MRMC Study: Not explicitly stated as a comparative effectiveness study showing human improvement. The study focuses on the algorithm's performance against ground truth.
    • Effect Size (Human Improvement with AI): Not reported.

    Auto Aorta Measure Assistant:

    • MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
    • Effect Size (Human Improvement with AI):
      • Long View Aorta (Keystrokes): Average keystrokes reduced from 4.132 (without AI) to 1.236 (with AI).
      • Short View Aorta (Keystrokes): Average keystrokes reduced from 7.05 (without AI) to 2.307 (with AI).
      • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

    Auto Common Bile Duct (CBD) Measure Assistant:

    • MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
    • Effect Size (Human Improvement with AI):
      • Porta Hepatis CBD (Keystrokes): Average reduction in keystrokes for measurements with AI vs. manually is 1.62 +/- 0.375.
      • (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).

    UGFF Clinical Study:

    • MRMC Study: No, this was a standalone algorithm performance study compared to a reference standard (MRI-PDFF) and a predicate device (UDFF). It did not involve human readers using the AI tool.

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

    Auto Abdominal Color Assistant 2.0:

    • Standalone Performance: Yes. The reported accuracy, sensitivity, specificity, and DICE score are for the algorithm's performance.

    Auto Aorta Measure Assistant:

    • Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth. While keystrokes involved human interaction to use the AI, the measurement accuracy is an algorithm output.

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth.

    UGFF Clinical Study:

    • Standalone Performance: Yes. The study directly assesses the correlation and agreement of the UGFF algorithm's output with MRI-PDFF and another ultrasound-derived fat fraction algorithm.

    7. The type of ground truth used

    Auto Abdominal Color Assistant 2.0:

    • Ground Truth Type: Expert consensus for anatomical visibility ("Readers to ground truth the 'anatomy' visible in static B-Mode image.")

    Auto Aorta Measure Assistant:

    • Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")

    UGFF Clinical Study:

    • Ground Truth Type: Outcomes data / Quantitative Reference Standard: MRI Proton Density Fat Fraction (MRI-PDFF %).

    8. The sample size for the training set

    Auto Abdominal Color Assistant 2.0:

    • Training Set Sample Size: Not specified beyond "The exams used for test/training validation purpose are separated from the ones used during training process".

    Auto Aorta Measure Assistant:

    • Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".

    UGFF Clinical Study:

    • Training Set Sample Size: Not specified. The study describes validation but not the training phase.

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

    Auto Abdominal Color Assistant 2.0:

    • Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy'".

    Auto Aorta Measure Assistant:

    • Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the AP measurement...".

    Auto Common Bile Duct (CBD) Measure Assistant:

    • Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the diameter...".

    UGFF Clinical Study:

    • Training Set Ground Truth: Not specified for the training set, but for the validation set, the ground truth was MRI-PDFF measurements.
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