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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.

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 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

For Auto Aorta Measure Assistant

For Auto Common Bile Duct (CBD) Measure Assistant

For UGFF Clinical Study

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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The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes 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/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The systems have a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.

The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

The Venue, Venue Go, Venue Fit and Venue Sprint systems can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue, Venue Go and Venue Fit systems are capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.

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

1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)

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

• Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
• Data Provenance:
  • Country of Origin: USA and Israel.
  • Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.

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

• Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
• Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).

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

• Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.

7. Type of Ground Truth Used (for ABV Test Set)

• Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.

8. Sample Size for the Training Set (for ABV)

• Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.

9. How the Ground Truth for the Training Set Was Established (for ABV)

• Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.

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Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic: Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system are 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 accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided text is a 510(k) summary for the GE Voluson Signature 20 and Signature 18 diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It does not describe an AI/software-as-a-medical-device (SaMD) study with specific acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).

The document states: "The subject of this premarket submission, Voluson Signature 20/18 did not require clinical studies to support substantial equivalence." This indicates that no specific performance study, clinical or otherwise, was conducted to demonstrate the device meets acceptance criteria using test sets, expert ground truth, or MRMC studies that would be typical for an AI/SaMD product.

Instead, the summary emphasizes that the new device shares fundamental scientific technology with its predicate, has the same clinical intended use (with additional migrated features from other cleared devices like Shearwave Elastography, which is an imaging mode, not an AI algorithm performing diagnostic interpretation), and complies with relevant safety and performance standards for ultrasound systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI component from this document because it does not describe such a study. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence for an ultrasound system, focusing on safety, fundamental technology, and similar intended use.

In summary, based on the provided text, the device did not undergo the type of study described in your request for AI/SaMD products.

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

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

The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.

The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.

The provided document contains information on two AI features: "Auto preset selection" and "Auto Abdominal Color Assistant". The acceptance criteria and study details for each are presented below.

Auto Preset Selection

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

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

• Test Set Sample Size:
  • Number of individual patients' images collected from: 50+ patients
  • Number of samples (images): 330+ images
• Data Provenance:
  • Country of Origin: USA (57%) and Australia (43%)
  • Retrospective/Prospective: Not explicitly stated, but the mention of "data collection protocol was standardized" suggests it might be retrospective collection of pre-existing data, or a controlled prospective study.

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

• Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
• Qualifications of Experts: "Certified sonographer/clinician." No years of experience or specific board certifications are mentioned.

4. Adjudication method for the test set:

• Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified as Pass or Fail by a certified sonographer/clinician." This implies a single expert verification without explicit multi-reader adjudication (e.g., 2+1 or 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No MRMC comparative effectiveness study was explicitly mentioned for this AI feature. The testing method described focuses on the AI's success rate verified by experts, not on comparing human performance with and without AI assistance.

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

• Yes, the "overall model success rate" refers to the algorithm's performance in suggesting views. The "verified as Pass or Fail by a certified sonographer/clinician" is likely a post-hoc verification of the algorithm's output, rather than an interactive human-in-the-loop study.

7. The type of ground truth used:

• Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail". This can be considered a form of "expert consensus" or "expert truth" (albeit with a single expert verification as mentioned in point 4).

8. The sample size for the training set:

• Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (330+ images from 50+ patients) is specified for the test set.

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

• Not explicitly stated. The document mentions that the test data was independent of the training data but doesn't detail the ground truth establishment for the training set. It's generally assumed that ground truth for training data in such AI applications would also be established by experts.

Auto Abdominal Color Assistant

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

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

• Test Set Sample Size:
  • Number of individual patients' images collected from: 40 patients
  • Number of samples (images): 280+ images
• Data Provenance:
  • Country of Origin: USA (35%) and Australia (65%)
  • Retrospective/Prospective: Similar to "Auto preset selection", not explicitly stated, but a "standardized data collection protocol" is mentioned.

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

• Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
• Qualifications of Experts: "Certified sonographer / clinician." No years of experience or specific board certifications are mentioned.

4. Adjudication method for the test set:

• Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified a Pass or Fail by a certified sonographer / clinician." This implies a single expert verification without explicit multi-reader adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No MRMC comparative effectiveness study was explicitly mentioned for this AI feature.

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

• Yes, the "overall model success rate" refers to the algorithm's performance. The "verified as Pass or Fail by a certified sonographer / clinician" is likely a post-hoc verification of the algorithm's output.

7. The type of ground truth used:

• Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail".

8. The sample size for the training set:

• Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (280+ images from 40 patients) is specified for the test set.

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

• Not explicitly stated. Similar to the "Auto preset selection" feature, it's assumed expert input would have been used for training data ground truth, but no details are provided.

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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 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.

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The Versana Essential is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.

Versana Essential is intended to be used in a hospital or medical clinic.

The Versana Essential is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.

The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.

The operator control panel includes function keys, trackball, an alfa-numeric keyboard.

The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port. The Video adapter is optional part which used to extend the S-Video/Composite Out interface by connecting with HDMI port. The system has a DC outlet to allow connection of a DC printer which sits in the printer box of the console and an option for external Printer USB Isolator for other commercial printers to connect.

The system allows for electronic instructions for use and software updates to be download from a GE Healthcare website.

The provided document is a 510(k) Premarket Notification Submission for the GE Versana Essential ultrasound system. It details the device's technical characteristics, intended use, and argues for its substantial equivalence to a predicate device (Versana Balance K220446).

However, this document does not contain any information regarding acceptance criteria, device performance metrics, or study details (sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance). The "Summary of Clinical Tests" section explicitly states: "The subject of this premarket submission, Versana Essential, did not require clinical studies to support substantial equivalence."

Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria, device performance, or study details.

The document primarily focuses on demonstrating substantial equivalence by comparing the Versana Essential to its predicate device Versana Balance (K220446) based on:

• Intended Use: Stated to be identical.
• Imaging Capabilities: Stated to be the same.
• Technological Characteristics: Stated to be the same fundamental technology, with minor differences in scan channels (Essential has fewer but safety/performance met) and absence of touch panel/Bluetooth in Essential.
• Imaging Modes: Stated to be identical.
• Hardware: Stated to be similar, with compliance to safety standards.
• Software: Stated to have the same features and functionality, with two minor exceptions not available in the Essential (whizz label and multi-touch).

The "Summary of Non-Clinical Tests" lists compliance with various electrical, electromagnetic, biocompatibility, and safety standards, but these are general safety and performance standards for the device as a whole, not specific performance metrics for an AI-powered diagnostic feature.

In summary, the provided text does not describe an AI feature or its associated acceptance criteria and performance study.

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EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

The provided FDA 510(k) summary for GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC's EchoPAC Software Only/EchoPAC Plug-in includes an "AI Summary of Testing" section for the Easy Auto EF and Easy AFI LV algorithms. This section provides information relevant to acceptance criteria and study details.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance figures, as they state the accuracy achieved.

Note: The document only provides Dice score for "accuracy." Other common performance metrics like sensitivity, specificity, or F1-score are not explicitly stated.

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

• Sample Size for Test Set:
  • Individual patients' images: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization).
  • Number of samples (images): 135 images extracted from the 45 exams.
• Data Provenance: Europe, Asia, US (retrospective, as indicated by anonymization and collection for testing).

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

• Number of Experts: Two certified cardiologists initially, with a panel of experienced experts for adjudication.
• Qualifications of Experts:
  • Two certified cardiologists (for initial manual delineation and review).
  • A panel of experienced experts (for reviewing annotations that the two cardiologists could not agree on). Specific years of experience are not mentioned beyond "experienced."

4. Adjudication Method

The adjudication method used was a 2+1 process (consensus followed by expert panel review):

1. Consensus Reading: Two certified cardiologists performed manual delineation and then reviewed each other's annotations. They discussed disagreements to reach a consensus.
2. Expert Panel Review: If the two cardiologists could not agree on an annotation, a panel of experienced experts further reviewed those annotations to establish the final ground truth.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the standalone performance of the AI algorithm. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm-only without human-in-the-loop performance) study was done. The reported Dice scores directly evaluate the algorithm's accuracy in segmenting regions of interest, independent of human interaction during the measurement process.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus. It was derived from manual delineations by certified cardiologists, with a further review and consensus by an expert panel for disagreements.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions that "datasets from different clinical sites for testing as compared to the clinical sites for training" were used.

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

The document does not explicitly state how the ground truth for the training set was established. It only describes the process for the test set's ground truth. However, it is generally assumed that similar expert-driven annotation processes would have been used for training data.

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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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Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician 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 EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 S60N / Vivid S70N consists of a mobile console with a height-adjustable 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, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE transducers.

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 USBadapter) connection.

The provided text focuses on the 510(k) premarket notification for the GE Vivid S60N/S70N ultrasound system. It details device descriptions, intended use, technological characteristics, and non-clinical tests. Crucially, it includes information on the "AI Summary of Testing: Easy Auto EF and Easy AFI LV," which addresses the performance of the AI algorithms incorporated into the device.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Study that Proves Device Meets Acceptance Criteria

The document states that the acceptance criterion for the AI algorithms (Easy Auto EF and Easy AFI LV) is an average dice score of 91% or higher across various testing conditions.

Study Proving Device Meets Acceptance Criteria:

The study involved testing the AI algorithms on datasets from different countries, scanning views, and left ventricle volumes.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The text states "92% or higher" and "91% or higher" for the reported performance, implying the acceptance criterion was at least 91%.

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

• Sample Size: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization). 135 images extracted from the 45 exams.
• Data Provenance:
  • Country of Origin: Europe, Asia, US (mixed data from different countries).
  • Retrospective/Prospective: Not explicitly stated, but the description of "data collection protocol was standardized across all data collection sites" and "During testing of the AI algorithm, we have included images from different countries..." suggests a pre-existing collected dataset, making it likely retrospective.

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

• Number of Experts:
  • Initial Delineation and Review: 2 certified cardiologists.
  • Consensus Review: A panel of experienced experts.
• Qualifications of Experts:
  • "Certified cardiologists" (for initial delineation and review).
  • "Experienced experts" (for the consensus review panel). Specific number of years of experience is not provided, but "certified" and "experienced" imply relevant qualifications.

4. Adjudication Method for the Test Set:

• Method: A multi-stage adjudication process was used:
  1. Two certified cardiologists performed manual delineation.
  2. They then reviewed each other's annotations.
  3. A "consensus reading" was performed where the two cardiologists discussed agreement/disagreement.
  4. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
• The final ground truth relied on annotations that the two cardiologists agreed upon, and the consensus annotations achieved by the expert panel.

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 was done. The information provided focuses on the standalone performance of the AI algorithm (Easy Auto EF and Easy AFI LV) in terms of Dice score accuracy for image segmentation, not on reader performance with or without AI assistance.

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 done. The reported "average dice score" is a metric for the algorithm's performance in automatically segmenting cardiac structures (Left Ventricle volume). The study describes the AI's accuracy in delineating these structures.

7. The Type of Ground Truth Used:

• Expert Consensus. The ground truth was established through manual delineation by certified cardiologists, followed by their mutual review, and a final consensus adjudicated by a panel of experienced experts.

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. The document only mentions that "To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training." This implies a training set existed and was distinct, but its size is not given.

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

• Not explicitly stated in the provided text. While the method for establishing ground truth for the test set is detailed, the process for the training set is not described. It is implied that ground truth was established, as AI models require labeled data for training, but the specific methodology is omitted.

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