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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/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (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 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 and Harmonic Imaging on a Display.

The provided text describes the ACUSON Redwood Diagnostic Ultrasound System and its substantial equivalence to predicate devices. However, it explicitly states that clinical studies were not required to support substantial equivalence because the device uses the same technology and principles as existing devices. Therefore, the document does not contain information about acceptance criteria, device performance from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on non-clinical tests demonstrating compliance with safety and performance standards.

Here's a breakdown of what cannot be provided based on the input text:

• Table of acceptance criteria and reported device performance: No clinical performance data is presented, and therefore no acceptance criteria related to such performance are defined or met by a specific study. The text largely refers to compliance with safety standards.
• Sample size used for the test set and the data provenance: No clinical test set was used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
• 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 done, and the device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of requiring such a study to demonstrate improved human reader performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is an ultrasound system, not a standalone algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical test set was used to establish a ground truth.
• The sample size for the training set: Not applicable as no clinical training set was mentioned for algorithm development in this context.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding non-clinical acceptance:

The device has been evaluated for and found to conform to various medical device safety standards. These can be considered the "acceptance criteria" for the non-clinical aspects.

Non-Clinical Acceptance Criteria and Study Findings (as per the document):

Summary of Clinical Study Absence:

The crucial piece of information for your request is found in Section 8:
"A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON Redwood Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

Therefore, there is no clinical study, test set, expert ground truth, adjudication method, MRMC study, or standalone performance data to report from this document. The substantial equivalence determination was based on the technological similarity to previously cleared predicate devices and compliance with non-clinical performance and safety standards.

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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 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.

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, 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 document is a 510(k) premarket notification for the Siemens ACUSON Sequoia Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the document explicitly states in section 8: "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."

This means that no clinical study was conducted to prove the device meets specific acceptance criteria based on human-in-the-loop performance or an AI’s standalone performance as would be the case for AI/ML-driven devices. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness studies or standalone AI performance.
• Ground truth establishment for test sets.
• Training set sample size or ground truth establishment relevant to AI/ML.

The provided information focuses on the device's technical specifications, safety standards compliance (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety), and engineering verification and validation, rather than clinical performance metrics for an AI/ML component.

The "acceptance criteria" presented in this document are primarily related to general device safety and performance based on engineering principles and comparison to predicate devices, rather than the kind of AI/ML performance metrics typically seen in studies demonstrating clinical efficacy or diagnostic accuracy for an AI-powered device.

Key takeaway: The document asserts substantial equivalence based on technological similarity to existing devices and compliance with safety standards, eliminating the need for new clinical performance studies for this specific submission.

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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 also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaqinal, 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 and Harmonic Imaging on a Display.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific acceptance criteria and performance data for new functions. The "acceptance criteria" here are implicitly the existing performance and safety characteristics of the predicate devices. The "reported device performance" is essentially that the ACUSON Sequoia Diagnostic Ultrasound System performs equivalently to its predicate devices.

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 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." This indicates that no specific "test set" of clinical data was used for this 510(k) submission to demonstrate performance with acceptance criteria, as the claim is based on equivalence to previously cleared devices.

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 new clinical studies or test sets with ground truth establishment by experts were conducted for this submission.

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

Not applicable, as no new clinical studies or test sets requiring adjudication were conducted for this submission.

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 is a submission for a diagnostic ultrasound system, not an AI-enabled device requiring a comparative effectiveness study in the context of human reader improvement.

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

Not applicable. This is not an AI algorithm. The submission is for a diagnostic ultrasound system.

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

Not applicable, as no new clinical studies were conducted to establish ground truth for new performance claims. The "ground truth" for the device's capabilities relies on the established safety and efficacy of its predicate devices, which would have undergone their own validation processes during their initial clearance.

8. The sample size for the training set

Not applicable, as there is no mention of a training set, indicating that this is not an AI/machine learning device that performs a diagnostic task for which it needs to be "trained."

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

Not applicable, as there is no training set mentioned.

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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, Musculoskeletal and Peripheral Vascular applications.

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 and Harmonic Imaging on a Display.

I am sorry, but the provided text does not contain the specific information required to answer your request.

Here's why:

• Acceptance Criteria and Reported Device Performance: The document is a 510(k) summary for a diagnostic ultrasound system (ACUSON Sequoia). While it lists various capabilities and features (e.g., modes of operation, clinical applications), it does not provide quantitative acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy, or any numeric scores) for how well the device performs these functions. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
• Study Details: Since no specific performance claims or acceptance criteria are stated, there is no detailed study described that proves the device meets such 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." This indicates that a pivotal clinical trial demonstrating performance against specific endpoints was not part of this submission for clearance.
• Missing Information: Consequently, all the other requested details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth type, and training set information are not present in this document because no such performance study is detailed.

The document focuses on establishing substantial equivalence based on:

1. Indications for Use: The system is intended to provide images and signals for various clinical applications (Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN, Cardiac, Pelvic, Vascular, Musculoskeletal, and Peripheral Vascular).
2. Technological Characteristics: Comparison of modes, frequencies, and features with predicate devices.
3. Safety and Compliance: Adherence to various IEC and ISO standards for acoustic output, biocompatibility, electrical safety, etc.

It operates under the assumption that since the technology and intended use are substantially equivalent to previously cleared devices, explicit performance studies comparing against rigid acceptance criteria are not necessary for this 510(k) clearance.

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