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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 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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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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