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The Sequoia™ Ultrasound System in conjunction with the administration of ultrasound contrast agents applies ultrasound energy to an organ, vessel/structure to improve opacification, increase delineation, enhance color Doppler and/or spectral Doppler response, increase visualization of blood flow, document uptake of contrast agent and/or demonstrate perfusion of tissue. The images obtained are useful to physicians in detecting normal and abnormal conditions in regions of the body.
The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The TE-V5M transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 8L5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 6L3 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 15L8 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 8V5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 7V3c transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 5 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction in a The 5 v 2c transducer is intended for flamonio incepts as at they have been approved".
The 3 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction ing the support of the same of of alles indications that they have been approved". The 3V2c transducer is intended for flamont maging and the mave been approved".
The 8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 5C2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The 4V2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The EV-8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".
The Aux CW transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".

The Sequoia™ Ultrasound System with the Harmonic Imaging with Contrast utilizes the previously cleared Sequoia™ Ultrasound system (Acuson Model 3001- K935595/S1) and its transcutaneous as well as invasive transducers to create 2-D, M-mode, color Doppler and Spectral Doppler displays of acoustic data in conjunction with administration of ultrasound contrast agent. There are two primary methods by which images are created. First, the images are created in primary imaging mode, with exactly the same transmit and receive settings and controls as are utilized for routine ultrasound imaging without contrast agent administration. Second, images are created in harmonic imaging mode, with the images created using the same transmit settings and controls as are utilized for routine ultrasound imaging without contrast agent administration but in addition the receive frequency is a multiple of the transmit frequency. In both primary and harmonic imaging, exams can be performed using the standard frame rates applicable during routine ultrasound exams. the number of cycles utilized in routine exams.

The provided document is a 510(k) submission for the Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option. It serves as a regulatory notification of intent to market the device, asserting its substantial equivalence to previously marketed devices. However, it does not explicitly contain acceptance criteria (e.g., performance metrics, thresholds) or detailed study results that "prove the device meets acceptance criteria" in the way a clinical trial report would for a novel device.

The "IMAGING PERFORMANCE" section [2] briefly states: "Clinical studies were conducted to verify the performance of the system in all imaging modes. Clinical data was submitted as part of the Harmonic Imaging with Contrast 510(k)." This indicates that performance verification was done, but the specifics of what was measured, what the acceptance criteria were, and what the results were are not elaborated in the provided text.

Therefore, many of the requested details cannot be extracted from this document.

However, based on the information available, here's what can be provided:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission primarily focuses on demonstrating that the addition of "Harmonic Imaging with Contrast" does not introduce new safety concerns and operates effectively within the existing cleared Sequoia™ Ultrasound system's capabilities.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states "Clinical studies were conducted to verify the performance of the system in all imaging modes. Clinical data was submitted as part of the Harmonic Imaging with Contrast 510(k)." [2] However, it does not provide details on:

• Sample size used for the test set.
• Data provenance (e.g., country of origin).
• Whether the studies were retrospective or prospective.

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)

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.

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

The document does not describe any adjudication method for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This device is an ultrasound system and its imaging modes, not an AI-assisted diagnostic tool in the contemporary sense.

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

This question is not applicable as the device described is an ultrasound imaging system with new imaging modes, not an algorithm, and it explicitly involves human-in-the-loop operation for image acquisition and interpretation by physicians.

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

The document does not specify the type of ground truth used in the clinical studies. Given the nature of an ultrasound system, it is common for the ground truth to be established by clinical diagnoses, pathology, or comparison with other established imaging modalities, but this is not confirmed in the text.

8. The sample size for the training set

This document describes a medical device (ultrasound system) undergoing 510(k) clearance, which typically does not involve a "training set" in the context of machine learning. The clinical studies mentioned were for verification of system performance. Therefore, a "training set" is not applicable in this context.

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

As there is no "training set" in the context of this device, this question is not applicable.

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