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The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.

The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."

Here's an analysis of the acceptance criteria and the study information provided:

Acceptance Criteria and Reported Device Performance

The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.

Study Details for Liver Elastography Optimization (SWE Performance Testing)

The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.

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

   • Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
   • Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.

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

   • Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
   • Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.

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

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.

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

   • Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.

6. The Type of Ground Truth Used:

   • Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.

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

   • Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.

Summary regarding AI components:

While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.

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ACUSON Sequoia and Sequoia Select

The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Origin and Origin ICE

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of. or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric. OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume lmaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

This document describes the acceptance criteria and study that proves the device called ACUSON Sequoia Diagnostic Ultrasound System from Siemens Medical Solutions USA, Inc. meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The submission details two AI features: "AI Abdomen" and "Trace AI."

AI Abdomen

Trace AI

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

AI Abdomen:

• Sample Size: 105 exams from individual patients, resulting in 1,785 images extracted (15 B-Mode images per view and per transducer).
• Data Provenance: Retrospective, collected from 3 institutions in the United States.

Trace AI:

• Sample Size: 10 different adult patients, from which 24 volumes were extracted.
• Data Provenance: Retrospective, collected from three institutions in the US, Mexico, and Germany.

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

AI Abdomen:

• Number of Experts: Three clinical users.
• Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.

Trace AI:

• Number of Experts: Three clinical users.
• Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.

4. Adjudication Method for the Test Set

AI Abdomen:

• For view classification, the ground truth was associated with each image at the time of imaging using a system protocol, implying a single determination at the point of acquisition.
• For semi-automated measurements, ground truth measurements were provided by three clinical users. The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for these measurements, but the acceptance criterion of Individual Equivalence Coefficient (IEC) suggests a comparison of the algorithm's results against these expert measurements.

Trace AI:

• Ground truth measurements were provided by three clinical users. Each sonographer independently refined the initial circle provided by Trace AI to annotate the underlying orifice structure. They could only see their own annotations. The contour created by sonographers (Ground Truth) was then compared with the contour detected by Trace AI (Detection Truth). This implies a comparison against each expert's delineation, potentially implying an aggregation or statistical analysis of agreement rather than a formal consensus adjudication before comparison with the AI.

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

• No MRMC comparative effectiveness study was explicitly mentioned in the provided text, and therefore, no effect size of human readers' improvement with AI vs. without AI assistance can be determined from this information. The studies described are performance evaluations of the AI algorithms themselves against ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, the studies described for both "AI Abdomen" and "Trace AI" are standalone performance evaluations of the algorithms. They assess the algorithms' accuracy in view classification, semi-automated measurements, and segmentation (DICE coefficient) against established ground truth without a human-in-the-loop component for the performance measurement. The "AI Abdomen" notes testing "with and without users editing the landmark locations" for measurements, implying that the algorithm's initial measurement (standalone) was evaluated. "Trace AI" describes experts refining initial circles given by Trace AI, and then comparing the expert-refined contour to the contour detected by Trace AI algorithm, further confirming a standalone evaluation of the algorithm's output.

7. Type of Ground Truth Used

AI Abdomen:

• View Classification: Ground truth view labels were associated with each image at the time of imaging using a system protocol. This suggests a form of expert labeling or pre-categorization at the point of data capture.
• Semi-automated Measurements: Expert consensus (or at least independent expert measurements) provided by three registered Clinical Sonographers.

Trace AI:

• Expert consensus/independent expert annotations: Ground truth measurements (delineations of orifice structures) were provided by three registered Clinical Sonographers independently.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set for either AI Abdomen or Trace AI. It only focuses on the test set and ensures its independence from the training data.

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 mentions that the testing dataset was from different clinical sites than those used for training, to ensure independence.

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The ACUSON Redwood ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Transcranial, and Peripheral Vascular.

The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures: fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial), and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Redwood Diagnostic Ultrasound System is multi-purpose, mobile, softwarecontrolled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, Combination modes, Harmonic Imaging and 3D Imaging modes, and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The provided document is a 510(k) summary for the ACUSON Redwood Diagnostic Ultrasound System. The core of the study described focuses on the new "Ultrasound-Derived Fat Fraction (UDFF)" feature. The general diagnostic ultrasound system itself is noted to use "the same technology and principles as existing predicate devices" and therefore "clinical studies were not required to support substantial equivalence" for its broader functionality. The following information pertains specifically to the UDFF feature.

Acceptance Criteria and Device Performance (UDFF Feature)

Further Study Details for UDFF Feature:

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Study 1: N = 30 subjects
     • Ethnicity/Country: 15 from USA, 15 from Korea
     • Sex: 15 Male, 15 Female
     • Retrospective or Prospective: Not explicitly stated, but the description of "To verify the clinical reliability...To record the UDFF measurement acquisition time" suggests it was a prospective data collection for this study.
   • Study 2: N = 28 subjects
     • Ethnicity/Country: 28 from Korea
     • Sex: 20 Male, 8 Female
     • Retrospective or Prospective: Not explicitly stated, but given the objective "To verify that UDFF of ACUSON Redwood shows good agreement with MRI-PDFF" and "To verify the clinical accuracy...", it implies prospective data collection where both UDFF and MRI-PDFF were acquired for correlation.

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

   • Study 1: This study primarily focused on comparing the ACUSON Redwood UDFF to the ACUSON Sequoia UDFF and internal consistency (test-retest reliability). Ground truth, in the sense of a definitive diagnostic outcome, was not the primary endpoint that would require expert adjudication. The "ground truth" here is the measurement from the established predicate device (ACUSON Sequoia UDFF) and the consistency of the Redwood's own measurements.
   • Study 2: The ground truth for this study was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). This MRI-PDFF is considered a quantitative reference standard for liver fat quantification. The document does not specify the number of human readers/experts directly involved in establishing the MRI-PDFF values for the study, as MRI-PDFF is typically an objective, quantitative measurement derived from MRI sequences and software, rather than a subjective expert read needing adjudication.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truths (predicate device measurements and MRI-PDFF) are presented as objective measurements and not subjective expert interpretations requiring adjudication.

4. 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or performed for the UDFF feature as described. The UDFF is a standalone software tool for measurement.

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

   • Yes, the studies evaluate the performance of the UDFF software tool itself in its ability to quantify fat fraction, either compared to a predicate device's software tool (Study 1) or to MRI-PDFF as a reference standard (Study 2). The results (Pearson Correlation, ICC, bland-Altman, AUROC) are metrics of the algorithm's performance.

6. The type of ground truth used:

   • Study 1: The ground truth was the Ultrasound-Derived Fat Fraction (UDFF) measurement obtained from the predicate device (ACUSON Sequoia), and the internal consistency of the ACUSON Redwood UDFF measurements (test-retest).
   • Study 2: The ground truth was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is a quantitative imaging biomarker considered a non-invasive gold standard for liver fat content.

7. The sample size for the training set:

   • The document does not provide information regarding the sample size of any training set used for the UDFF algorithm. This section focuses on validation studies.

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

   • The document does not provide information regarding how the ground truth for any potential training set was established.

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ACUSON Sequoia and Sequoia Select

The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Origin and Origin ICE

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures). Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text, specifically for the expansion of the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to pediatrics:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of individual patients: 105 patients.
  • 40 patients scanned with the DAX transducer.
  • 27 patients with the 5C1 transducer.
  • 38 patients with the 9C2 transducer.
• Number of samples: 525 measurements (Five UDFF measurements were obtained per patient).
• Data Provenance: Data were collected from two institutions in the US and France. The studies tested UDFF in children during clinically indicated MRI procedures.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). It only states that "MRI PDFF was used as the reference standard." The interpretation and establishment of ground truth from MRI-PDFF would typically involve qualified medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The reference standard used was MRI-PDFF, which is a quantitative measure and therefore may not have required such an adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with and without AI assistance was not reported. The study focused on the performance of the UDFF tool itself against a reference standard.

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

Yes, the testing described appears to be for the standalone performance of the UDFF algorithm. The criteria and results focus on the measurements generated by the UDFF tool (AUROC, ICC, exam time) in comparison to the MRI-PDFF reference standard. While the tool is intended to "aid a physician," the performance metrics presented demonstrate the algorithm's capability independent of direct human interaction in the evaluation setup.

7. The Type of Ground Truth Used

The ground truth used was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). Steatosis was defined as MRI-PDFF greater than 5%.

8. The Sample Size for the Training Set

The document explicitly states that the UDFF algorithm remained unchanged and was not retrained for these studies. Therefore, no specific training set sample size for this expansion is provided, as the existing algorithm developed for adults was applied to the pediatric population.

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

Since the UDFF algorithm was not retrained and remained unchanged, the document does not describe how the ground truth for its original training set was established. It only clarifies that the data from these pediatric studies were considered "test data to evaluate the performance of UDFF in children using MRI PDFF."

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ACUSON P500 Ultrasound System
The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

ACUSON P500 ICE Ultrasound System
The ACUSON P500 ICE ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

The ACUSON P500 and P500 ICE Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

The provided text is an FDA 510(k) clearance letter for the ACUSON P500 and P500 ICE Ultrasound Systems. It does not contain the specific details of acceptance criteria or a study proving the device meets those criteria. The document explicitly states:

"Since the ACUSON P500 and P500 ICE Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

This means that a specific clinical study with acceptance criteria, test sets, expert ground truth, etc., as requested in your prompt, was not performed or submitted for this particular clearance, as the device was deemed substantially equivalent to a previously cleared predicate device.

Therefore, I cannot provide the requested information from the given text.

If you have a document that describes the specific acceptance criteria and a study that proves the device meets them, please provide that document.

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The ACUSON SC2000 Diagnostic Ultrasound System is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with proprietary software and accessories. The function of the ACUSON SC2000 Diagnostic Ultrasound System is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, measurements, calculations, analysis of the human body and fluid flow, etc.

The provided document is a 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states that no clinical data was required or conducted to support substantial equivalence for this device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth details, as these clinical study elements were not performed.

The document focuses on non-clinical data to demonstrate safety and performance, primarily through compliance with voluntary standards and compatibility testing with existing catheters.

Here's a breakdown of what can be extracted from the document regarding the device's validation:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable as no clinical study with explicit acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) was conducted or reported in this 510(k) summary. The document focuses on showing compliance with performance standards for ultrasound systems generally and compatibility with specific catheters.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from patients was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound system and there is no mention of AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm-only device. Performance evaluations focused on the system's ability to generate ultrasound images and facilitate measurements, as well as its compatibility with certain catheters.

7. The type of ground truth used: Not applicable. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) was used as no clinical study was conducted.

8. The sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm, but rather the clearance of an ultrasound system.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device Validation based on the Provided Text:

The ACUSON SC2000 Diagnostic Ultrasound System's substantial equivalence to its predicate device (ACUSON SC2000 Diagnostic Ultrasound System v6.1 (VC11) K211726) is supported by non-clinical data.

• Rationale for No Clinical Data: "The proposed ACUSON SC2000 Diagnostic Ultrasound System did not require clinical studies to support substantial equivalence." (Page 9)
• Non-clinical Data Focus: The submission primarily demonstrates that:
  • The device complies with various voluntary standards related to medical electrical equipment, ultrasound field characterization, biological evaluation of medical devices, usability, risk management, software lifecycle process, and quality management systems (listed on pages 8-9).
  • The ACUSON SC2000 Diagnostic Ultrasound System v6.5 (VC15) is compatible with the AcuNav Crystal Ultrasound Catheter (K233270) and SoundStar Crystal Ultrasound Catheter (K240050), and the SwiftLink Plus Connector. This compatibility testing demonstrates that the system performs as intended with these accessory devices.
• Conclusion: "The non-clinical testing data support the safety of the device and demonstrate that the ACUSON SC2000 Diagnostic Ultrasound System is compatible with the AcuNav Crystal Ultrasound Catheter and the SoundStar Crystal Ultrasound Catheter and the system performs as intended in the specified use conditions. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 Diagnostic Ultrasound Systems are as safe and effective with substantially equivalent performance as the predicate device." (Page 9)

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ACUSON Sequoia and ACUSON Sequoia Select

The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic, structures), Cardiac, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Origin

The ACUSON Origin ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/ GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The ACUSON Sequoia, Sequoia Select, and Origin Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display of thermal and mechanical indices related to potential bio-effect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes. Panoramic Imaging. Contrast agent Imaging. Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

The provided FDA 510(k) summary describes the Siemens ACUSON Sequoia, ACUSON Sequoia Select, and ACUSON Origin Diagnostic Ultrasound Systems, focusing on new software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) that incorporate Machine Learning algorithms for cardiac imaging.

The document includes summaries of validation testing for each of these AI features.

1. Table of Acceptance Criteria and Reported Device Performance

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

3. Number of Experts and Qualifications for Ground Truth

4. Adjudication Method for the Test Set

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to measure the effect size of human readers improving with AI vs. without AI assistance. The studies performed focus on the standalone performance of the AI algorithms, often with user edits being factored in, but not a direct comparison of human performance with and without AI.

6. Standalone Performance Study

Yes, standalone performance studies were done for each AI feature:

• AI Assist: Evaluated the algorithm's ability to successfully place Color Box and Doppler Gate based on expert sonographer scoring of its output (99.3% success). This is a standalone assessment of the algorithm's initial placement accuracy.
• 2D HeartAI: Evaluated the accuracy of the 2D HeartAI "as measured by comparison of 2D HeartAI with user edits compared to a reference standard ground truth." While user edits are mentioned, the reported correlation coefficient and bias (0.81 or higher, bias < 5.2) represent the algorithm's performance leading to those edits or in conjunction with minor adjustments. The performance metrics are directly attributable to the algorithm's output.
• 4D HeartAI: Similar to 2D HeartAI, the accuracy of the AI algorithm was measured by comparing its output (with user edits) to a reference standard ground truth (0.87 or higher correlation, bias < 13.3).
• AI Measure: Evaluated the algorithm's success rate based on expert sonographer scoring of its measurements as clinically acceptable (89.6% success). This is a standalone assessment of the algorithm's measurement accuracy.

7. Type of Ground Truth Used

The ground truth for all AI features was based on expert consensus or expert-derived measurements:

• AI Assist: Expert cardiac sonographers provided "truth" by scoring the algorithm's results (success/failure of placement).
• 2D HeartAI: Three examiners performed manual contouring and measurements, and the mean value from these three examiners established the reference standard for each measurement.
• 4D HeartAI: Identical to 2D HeartAI, the mean value from three examiners performing manual contouring and measurements established the reference standard.
• AI Measure: Expert cardiac sonographers provided "truth" by scoring the algorithm's results ("measurements were deemed clinically acceptable").

8. Sample Size for the Training Set

The document does not provide explicit sample sizes for the training sets. It only states:

• "Testing was performed on patient data completely independent from the data used in the model development processes." (AI Assist)
• "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." (2D HeartAI, 4D HeartAI, AI Measure)

This indicates that separate datasets were used for training and testing, and that training data was also derived from clinical sites, but specific numbers are not given.

9. How Ground Truth for Training Set Was Established

The document does not explicitly describe how the ground truth for the training set was established. However, given the methodology for the test set, it can be inferred that similar expert-derived methods (manual contouring, measurements, scoring by expert sonographers/examiners) were likely used to prepare the training data, as is common practice in medical imaging AI development. The document only mentions that the sites for training data collection were different from those for testing.

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For ACUSON Maple Diagnostic Ultrasound System

The ACUSON Maple ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

For ACUSON Maple Select Diagnostic Ultrasound System

The ACUSON Maple Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediat, Urology, Echocardiography and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

The ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

The provided document is a 510(k) summary for the ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study with acceptance criteria.

Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document explicitly states:
"The proposed ACUSON Maple and ACUSON Maple Select did not require any clinical studies to support substantial equivalence."

This means that the device was cleared based on its similarity to previously cleared devices (ACUSON Juniper and Juniper Select (K230207), ACUSON NX2 and NX2 Elite (K173981), ACUSON SC2000 (K211726)) and non-clinical data demonstrating safety and adherence to voluntary standards.

Consequently, I cannot provide the requested table or describe a study that proves the device meets specific acceptance criteria based on the input text.

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For ACUSON Juniper

The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

For ACUSON Juniper Select

The ACUSON Juniper Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography and Musculoskeletal applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

The ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System are the multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

This is a 510(k) premarket notification for an ultrasound system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical performance data that would typically require specific acceptance criteria and a detailed study report.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of device performance, human reader improvement, and ground truth establishment is not available in the provided text.

The document states: "The subject of this premarket submission, ACUSON Juniper and ACUSON Juniper Select, did not require clinical studies to support substantial equivalence." This means that no specific clinical performance study was conducted to establish new performance metrics against predefined acceptance criteria for clinical diagnostic accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use and Technological Characteristics: The document includes tables comparing the new device's indications for use and features with those of the predicate device (K221190) and reference devices (K183575, K213487). The primary claim is that the new device is "substantially equivalent ... with regards to intended use, indications for use, technological characteristics (Transducers, accessories and software features) and safety and effectiveness."
• Nonclinical Tests: These tests focus on safety aspects like acoustic output, biocompatibility, cleaning/disinfection, thermal safety, electromagnetic compatibility, and mechanical safety, conforming to applicable medical device safety standards (e.g., IEC 62359, AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, ISO 10993-1).

In summary, there were no specific acceptance criteria for diagnostic performance established in this submission, nor was there a clinical study designed to demonstrate performance against such criteria. The "proof" of meeting acceptance criteria is the demonstration of substantial equivalence to already cleared devices based on technological similarity and nonclinical safety testing.

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The ACUSON Sequoia and Sequoia Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculosketal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems are a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

The provided text is a 510(k) summary for the Siemens ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria, especially for new or AI-driven features.

The most relevant section about specific performance is regarding the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool, which is described as reporting "an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis" (Page 3, Page 6). The document states that the modified ACUSON Sequoia Ultrasound System includes "the expansion of the UDFF (Ultrasonically-Derived fat fraction) software features for 5C1 transducer which were already cleared on the ACUSON Sequoia (K221500)" (Page 7). This implies that the UDFF feature itself was previously cleared.

However, the 510(k) submission does not provide details about acceptance criteria or a study proving the device meets these criteria for the UDFF feature or any other feature in the format requested. In fact, it explicitly states:

"Since the ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Page 10)

This statement indicates that their substantial equivalence argument relies on the technological similarity to existing cleared devices, and thus a detailed clinical performance study (including acceptance criteria, sample sizes, expert ground truth, etc.) was not performed for this specific 510(k) submission.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory submission for a diagnostic ultrasound system based on substantial equivalence, not a clinical study report for a novel AI/software feature with detailed performance metrics.

To directly answer your request based on the provided text, many fields will be "Not Applicable" or "Not Provided."

Here's how the information would map to your request if it were available in the document:

Acceptance Criteria and Device Performance Study for Siemens ACUSON Sequoia and Sequoia Select Diagnostic Ultrasound Systems (as per provided document)

Given the nature of the provided 510(k) summary, which relies on substantial equivalence and states that clinical studies were not required, many of the requested details are not present.

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

   Feature/Criterion	Acceptance Criteria (if stated)	Reported Device Performance (if stated)
   Ultrasonically-Derived Fat Fraction (UDFF) measurement tool	Not provided in this document	"an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis" (indicative only, no quantitative performance reported)
   General Device Performance	Not provided in this document	Relies on substantial equivalence to predicate device (K221500)
   Overall Conclusion	Not provided for specific features in a quantitative manner, as clinical studies were not required for this submission.	Not provided for specific features in a quantitative manner, as clinical studies were not required for this submission.

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

   • Test Set Sample Size: Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.
   • Data Provenance: Not applicable / Not provided.

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

   • Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.

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

   • Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.

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 study was performed or reported in this document. The submission states, "clinical studies were not required to support substantial equivalence."

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

   • No standalone performance study reported in this document. The submission states, "clinical studies were not required to support substantial equivalence."

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

   • Not applicable / Not provided, as clinical studies were not required for this 510(k) based on substantial equivalence.

8. The sample size for the training set

   • Not applicable / Not provided. This document does not describe the development or training of an AI algorithm; rather, it describes a diagnostic ultrasound system relying on existing technology and a predicate device. The UDFF is a "software feature" that was "already cleared" on a previous device.

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

   • Not applicable / Not provided, for the same reasons as above. The document does not detail the training of any new AI/software feature unique to this submission.

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