(55 days)
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.
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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. -
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.
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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.
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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.
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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."
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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."
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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.
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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.
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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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.