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

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 highresolution color touch screen and 23.8-inch High Contrast LED LCD monitor.

Here's a breakdown of the acceptance criteria and study details for the "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant" features of the GE LOGIQ E10, based on the provided FDA 510(k) summary:

The document provides information for two distinct AI features: "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant". I will detail the information for each separately.

Auto Renal Measure Assistant

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 30 patients, resulting in 60 images (30 Longitudinal views and 30 Transverse views).
• Data Provenance:
  • Country of Origin: USA (58%) and Japan (42%).
  • Retrospective/Prospective: Prospectively collected.

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

• Number of Experts: 2 Readers (certified sonographer/Clinician) and 1 Board Certified Nephrologist.
• Qualifications: "Certified sonographer/Clinician" for the initial readers; "Board Certified Nephrologist" for the arbitrator. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: A Board Certified Nephrologist arbitrated the ground truth between the two initial readers to establish the reference standard. This resembles a "2+1" or "tie-breaker" adjudication.

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

• No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not specified for this feature. The study focused on the algorithm's performance against expert-established ground truth.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Yes, the reported accuracies (96.45%, 92.94%, 93.13%) represent the standalone performance of the algorithm in measuring renal dimensions against the established ground truth.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (between two sonographers/clinicians, arbitrated by a nephrologist).

8. The Sample Size for the Training Set

• The document states that the verification data was acquired independently during validation after the development of the model. The sample size for the training set is not provided in this summary.

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

• The method for establishing ground truth for the training set is not specified in this summary. Only the method for the independent verification (test) set is described.

Auto Abdominal Color Assistant / Auto Preset Assistant

(Note: The document lists "Auto Abdominal Color Assistant" and then immediately below it, and seemingly as a continuation or related feature, "Auto Preset Assistant" with similar testing information. I will treat them as two related or broadly similar features based on the provided structure.)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Auto Abdominal Color Assistant:
  • Sample Size: 50+ patients, resulting in 1100+ images.
  • Data Provenance:
    • Country of Origin: USA (77%) and Australia (23%).
    • Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.
• Auto Preset Assistant:
  • Sample Size: 110+ patients, resulting in 2600+ images.
  • Data Provenance:
    • Country of Origin: USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).
    • Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.

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

• Number of Experts: Unspecified number of "Readers (certified sonographer/Clinician)".
• Qualifications: "Certified sonographer/Clinician". Specific years of experience or precise number of experts not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The summary states, "Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image." It doesn't mention multiple readers for the same image or an adjudication process if there were discrepancies.

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

• No, an MRMC comparative effectiveness study was not specified for these features. The testing described is for the standalone algorithm's accuracy in view suggestion.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Yes. The core of the testing involved running the AI and comparing its predictions to the ground truth to calculate the accuracy of the algorithm against each class. This represents standalone performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert annotation by "certified sonographer/Clinician" on B-mode images ("anatomy visible").

8. The Sample Size for the Training Set

• The document states that exams used for test/training validation were separated with no overlap. However, the specific sample size for the training set is not provided.

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

• The method for establishing ground truth for the training set is not specified. Only the method for the independent test set is described.

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The LOGIQ E10s and LOGIQ Fortis are 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, 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 and LOGIQ Fortis are intended to be used in a hospital or medical clinic.

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.
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).

The provided text describes three AI features of the LOGIQ E10s and LOGIQ Fortis systems: Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant. The information provided for each feature allows for a detailed breakdown of their acceptance criteria and the studies conducted to prove they meet these criteria.

Here's the requested information structured for clarity:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance for Test Sets

• Auto Renal Measure Assistant:
  • Test Set Sample Size: 30 patients, resulting in 60 samples (30 longitudinal views, 30 transverse views).
  • Data Provenance: Prospective collection. Data from USA (58%) and Japan (42%).
• Auto Abdominal Color Assistant:
  • Test Set Sample Size: 50+ patients, resulting in 1100+ images.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (77%) and Australia (23%).
• Auto Preset Assistant:
  • Test Set Sample Size: 110+ patients, resulting in 2600+ images.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).

3. Number of Experts and Qualifications for Ground Truth

• Auto Renal Measure Assistant:
  • Number of Experts: 2 "Readers" and 1 "Board Certified Nephrologist" for arbitration.
  • Qualifications: "certified sonographer/Clinician" for the two readers. "Board Certified Nephrologist" for the arbitrator.
• Auto Abdominal Color Assistant:
  • Number of Experts: Unspecified number of "Readers".
  • Qualifications: "certified sonographer/Clinician" for the readers.
• Auto Preset Assistant:
  • Number of Experts: Unspecified number of "Readers".
  • Qualifications: "certified sonographer/Clinician" for the readers.

4. Adjudication Method for Test Sets

• Auto Renal Measure Assistant:
  • Method: A "Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard". This implies a 2+1 (two readers, one arbitrator) method.
• Auto Abdominal Color Assistant & Auto Preset Assistant:
  • Method: The text states, "Readers (certified sonographer/Clinician) to ground truth the 'anatomy' visible in static B-Mode image." There is no mention of multiple readers or an arbitration process, implying no explicit inter-reader adjudication method was described beyond individual expert annotation.

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

• No MRMC comparative effectiveness study was explicitly described in the provided text. The studies focus on the standalone performance of the AI algorithms against a derived ground truth, rather than comparing human reader performance with and without AI assistance. Therefore, no effect size for human readers' improvement with AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone (algorithm only) performance studies were done for all three AI features listed. The studies evaluate the accuracy or success rate of the AI algorithms in performing their intended functions (measurement, view suggestion) against an established ground truth, without a human-in-the-loop component being explicitly tested or reported.

7. Type of Ground Truth Used

• Auto Renal Measure Assistant: Expert Consensus, as it involved two readers and an arbitrator to establish the reference standard for measurements.
• Auto Abdominal Color Assistant & Auto Preset Assistant: Expert Annotation/Consensus, established by "Readers (certified sonographer/Clinician) to ground truth the 'anatomy'visible in static B-Mode image." While not explicitly stated as consensus among multiple readers, it is established by qualified experts.

8. Sample Size for Training Sets

• The training set sample sizes are not explicitly provided in the summaries for any of the AI features. The document only mentions that the "verification data was acquired independently during validation process after the development of the model," and "The exams used for test/training validation purpose are separated from the ones used during training process." This implies training data existed but its size is not detailed.

9. How Ground Truth for Training Sets Was Established

• The document does not explicitly describe how the ground truth for the training sets was established. It focuses primarily on the process for the test/validation sets. However, it can be inferred that a similar process involving expert clinicians/sonographers would have been used to establish ground truth for training data, as is common practice in medical imaging AI development.

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The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

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

LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.

It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and control panel with new keyboard.

The system has digital acquisition, processing and display capability and operates from an integrated battery or AC/DC power adapter. It has one battery pack as standard configuration and also with an optional battery pack to be provided for additional power for longer scanning time.

The system also has an optional height-adjustable cart for comfortable standing and sitting positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to 1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to supply the system power from the cart.

LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, TEE.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The system supports electronic delivery of software. The system allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system. Download from the GEHC website requires an account.

The provided text does NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a GE Medical Systems Ultrasound device, the LOGIQ e. It primarily focuses on demonstrating substantial equivalence to a predicate device and other reference devices, not on the performance of a new AI-powered feature with specific acceptance criteria.

The document discusses:

• Device Name: LOGIQ e
• Regulation Number/Name: 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System
• Regulatory Class: Class II
• Product Codes: IYN, IYO, ITX
• Indications for Use: General purpose diagnostic ultrasound for various clinical applications.
• Predicate Device: LOGIQ e (K151028)
• Reference Devices: Vivid iq (K221148), Versana Premier (K210438), Venue Go (K202233)
• Changes/Additions: New transducers, software features (AutoEF, Scan assistant, Strain Elastography, Probe check, Imaging Insights, Tricefy Uplink), hardware (new industrial design, secondary battery option, thermal solution), and accessories.
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, compliance with various IEC, ISO, AAMI, and NEMA standards. Quality assurance measures like risk analysis, design reviews, and testing are mentioned.
• Clinical Tests: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the test and training sets, as these details are not present in the provided context. The submission is for a general diagnostic ultrasound system and not for a specific AI algorithm with performance metrics.

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The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, and dual array including dedicated CW transducers.

The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.

The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.

The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.

The GE Vivid T8/Vivid T9 ultrasound system includes AI algorithms named Easy Auto EF and Easy AFI LV. The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of Individual Patients' Images: 135 images
• Number of Exams: 45 exams (assumed 45 patients, exact number of patients unknown due to anonymization)
• Data Provenance:
  • Country of Origin: Europe, Asia, US
  • Retrospective/Prospective: Not explicitly stated, but implies retrospective collection from various clinical sites.

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

• Initial Ground Truth Establishment: Two certified cardiologists.
• Adjudication Panel: A panel of experienced experts. Specific number and years of experience not provided, beyond "experienced experts."

4. Adjudication Method for the Test Set

The adjudication method appears to be a 2 + 1 method (or similar consensus-based approach):

1. Two certified cardiologists performed manual delineation and reviewed each other's annotations.
2. A consensus reading was conducted where the two cardiologists discussed their agreement.
3. For annotations where the two cardiologists could not agree, a panel of experienced experts further reviewed and established the consensus.
4. The final ground truth comprised annotations agreed upon by the two cardiologists, and the consensus annotations from the expert panel review.

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

No, an MRMC comparative effectiveness study was not conducted. The document focuses on the standalone performance of the AI algorithm.

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

Yes, a standalone performance evaluation of the AI algorithm was conducted, specifically measuring the accuracy (Dice score) of the AI algorithm(s) against an established ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus. It was established through a multi-step process involving initial independent delineation by two certified cardiologists, their consensus discussions, and further review by a panel of experienced experts for disagreements.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It only states that the testing dataset was independent of the training data.

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

The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the testing dataset was ensured to be independent from the training data by using datasets from "different clinical sites for testing as compared to the clinical sites for training."

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The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.

There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the performance of the AI algorithms, "Easy Auto EF" and "Easy AFI LV," which are components of the Vivid iq system. The primary acceptance criterion appears to be the accuracy of the AI algorithm in terms of its Dice score.

Note: The document only provides performance metrics for the AI algorithms specifically, not for the entire Vivid iq system's overall clinical performance beyond safety and equivalence to predicates for its general ultrasound functions.

Study Details for AI Algorithms (Easy Auto EF and Easy AFI LV)

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

• Number of images: 135 images.
• Number of exams: 45 exams.
• Assumed number of patients: 45 patients (exact number unknown due to anonymization).
• Provenance: Retrospective data collected from different countries, including Europe, Asia, and the US. The document states that the testing dataset came from different clinical sites than the training data to ensure independence.

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

• Initial Experts: Two certified cardiologists.
• Adjudication Panel: An unspecified "panel of experienced experts" for cases where the initial two cardiologists did not agree. Specific qualifications for the panel are not provided beyond "experienced experts."

4. Adjudication method for the test set:

• Primary Method: Consensus reading between two certified cardiologists. They performed manual delineation and then reviewed each other's annotations. They discussed and agreed upon annotations.
• Secondary Method: For annotations where the two cardiologists could not agree, a "panel of experienced experts" further reviewed and established a consensus ground truth. This suggests a 2+1 (or 2+N) approach for disagreements.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The evaluation focuses solely on the standalone performance of the AI algorithm against expert-established ground truth.

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

• Yes, a standalone performance evaluation of the AI algorithm was conducted. The reported Dice scores (91-92% or higher) reflect the algorithm's accuracy in autonomously delineating structures.

7. The type of ground truth used:

• Expert consensus was used as the ground truth. This was derived from manual delineations by two certified cardiologists, with a panel of experienced experts resolving disagreements.

8. The sample size for the training set:

• The sample size for the training set is not specified in the provided document. It only mentions that datasets from different clinical sites were used for training compared to the test set.

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

• The document does not explicitly describe how the ground truth for the training set was established. However, given the description for the test set, it is highly probable that a similar expert-driven delineation and consensus process was used.

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