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Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis.

The device is intended to be used in a clinical setting and by trained medical professionals.

Velacur is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the orqan of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam.

The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation.

Minor hardware and software changes were made to the organ guide (cleared in K223287) was also extended to add more optional overlays on top of the liver overlay to help with optimizing the scan and training users to obtain adequate images. The significant change is the addition of a new output measure for Velacur, an ultrasound derived fat fraction (VDFF).

Here's a breakdown of the acceptance criteria and study details for the Velacur device, as described in the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two separate machine learning algorithms: the Velacur Determined Fat Fraction (VDFF) algorithm, the Organ Guide Extension, and the Wave Quality Guide. Each has its own acceptance criteria and performance metrics.

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

• Velacur Determined Fat Fraction (VDFF):

  • Test Set Sample Size: 70 new patients
  • Data Provenance: From 3 separate sites (with different Velacur operators). Implied to be prospective, as it's separate from the training data. The document states "Data was collected from sites across the US and Canada" for training, and "Evaluation data was collected... from separate patients, sites and collected by different users than the data used for training in order to ensure data independence," suggesting a similar geographical distribution for the test set. Retrospective/prospective not explicitly stated for this particular validation cohort, but the nature of MRI scans for ground truth implies it would be collected alongside the Velacur scans.

• Organ Guide Extension:

  • Test Set Sample Size: More than 800 images from 21 patients.
  • Data Provenance: "Evaluation data was collected from volunteers and patients with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. All patients were recruited from hepatology clinics." Data was collected from sites across the US and Canada (implied to be similar for evaluation as for training). Data for evaluation was explicitly stated to be from "separate patients, sites and collected by different users than the data used for training," indicating an independent, possibly prospective collection for evaluation.

• Wave Quality Guide:

  • Test Set Sample Size: More than 4,000 images from 36 patients.
  • Data Provenance: "Evaluation data was collected from volunteers and patients with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. All patients were recruited from hepatology clinics." Data was collected from sites across the US and Canada (implied to be similar for evaluation as for training). Data for evaluation was explicitly stated to be from "separate patients, sites and collected by different users than the data used for training," indicating an independent, possibly prospective collection for evaluation.

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

• Velacur Determined Fat Fraction (VDFF):

  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified. The MRI scans were "assessed to create the final measurement," implying expert interpretation without explicitly stating the number or qualifications.

• Organ Guide Extension:

  • Number of Experts: Not specified.
  • Qualifications of Experts: "experts in the field of sonography and/or ultrasound elastography." No specific experience level (e.g., years) is provided.

• Wave Quality Guide:

  • Number of Experts: Not specified.
  • Qualifications of Experts: "experts in the field of ultrasound elastography." No specific experience level (e.g., years) is provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for establishing ground truth for any of the algorithms. It generally states that ground truth was established by experts or through MRI-PDFF assessment, implying a single assessment per case or a consensus without detailing the process.

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 reported in this document. The studies focus on the standalone performance of the AI algorithms.

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

Yes, standalone performance studies were done for all three components:

• Velacur Determined Fat Fraction (VDFF): The reported correlation coefficient and AUC are measures of the algorithm's direct performance against a ground truth (MRI-PDFF).
• Organ Guide Extension: The Dice Coefficient and pixel accuracy measure the algorithm's ability to segment organs directly.
• Wave Quality Guide: The Dice Coefficient, sensitivity, and specificity measure the algorithm's direct ability to identify good quality waves.

7. The Type of Ground Truth Used

• Velacur Determined Fat Fraction (VDFF): MRI Proton Density Fat Fraction (MRI-PDFF). This is considered a highly accurate quantitative measure for liver fat.
• Organ Guide Extension: Manual image segmentation by experts.
• Wave Quality Guide: Manual image segmentation by experts.

8. The Sample Size for the Training Set

• Velacur Determined Fat Fraction (VDFF): 112 patients from 4 sites (used for parameter fitting/training).
• Organ Guide Extension: More than 5,000 patient images.
• Wave Quality Guide: More than 15,000 patient images from 100+ patients.

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

• Velacur Determined Fat Fraction (VDFF): MRI-PDFF scans were assessed to create the final measurement.
• Organ Guide Extension: Manual image segmentation by experts in the field of sonography and/or ultrasound elastography.
• Wave Quality Guide: Manual image segmentation by experts in the field of ultrasound elastography.

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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 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, 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.

The ACUSON Sequoia Diagnostic Ultrasound System is 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, 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, 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.

Theprovided text primarily focuses on the FDA's substantial equivalence determination for the ACUSON Sequoia Diagnostic Ultrasound System, explaining that clinical studies were not required as the device uses the same technology and principles as existing devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical performance study.

However, I can extract the information provided about the device's characteristics and the non-clinical tests relied upon for substantial equivalence.

Here's a breakdown of the available information in relation to your request, highlighting what is not present:

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

This information is not provided in a clinical performance context. The document states that clinical studies were not required for substantial equivalence. The "acceptance criteria" here relate to compliance with regulatory standards and equivalency to predicate devices.

• IEC 62359: Edition 2.1 2017-09
• AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
• IEC 60601-1:2005
• IEC 60601-1-2 Edition 4.0 2014-02
• IEC 60601-2-18: Edition 3.0 2009-08
• IEC 60601-2-37 Edition 2.1 2015
• ISO 10993-1 Edition 2.1 2017-09 |
  | Substantial Equivalence to predicate devices in intended use and technological characteristics | The ACUSON Sequoia Diagnostic Ultrasound System is substantially equivalent to ACUSON Sequoia (K201462) and ACUSON S family (K183575) regarding intended use and technological characteristics. |
  | Inclusion of new or improved features | Updated indications for use to add UDFF (Ultrasonically-Derived Fat Fraction), Auto pSWE, Auto IMT, eSieDoppler, Virtual Workstation, and Image Rotate (features previously cleared on predicate/reference devices). |
  | Design and development process conforms to quality system regulations | Conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. |

Regarding a clinical study proving device meets acceptance criteria:

The document explicitly states: "Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Page 9)

Therefore, the following information points are not applicable or not available from the provided text for a clinical performance study:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical performance study was conducted.

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, as no clinical performance study was conducted. The document doesn't mention AI assistance in this context, only new features.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as no clinical performance study was conducted.

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

8. The sample size for the training set:
Not applicable, as no clinical performance study was conducted using a training set in the context of a new algorithm requiring performance evaluation.

9. How the ground truth for the training set was established:
Not applicable, as no clinical performance study was conducted using a training set.

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