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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 Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Transcranial, and Peripheral Vascular.

The system supports the Ultrasound-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: fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (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 multi-purpose, mobile, softwarecontrolled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its 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 mode, Amplitude Doppler Mode, Combination modes, Harmonic Imaging and 3D Imaging modes, and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The provided document is a 510(k) summary for the ACUSON Redwood Diagnostic Ultrasound System. The core of the study described focuses on the new "Ultrasound-Derived Fat Fraction (UDFF)" feature. The general diagnostic ultrasound system itself is noted to use "the same technology and principles as existing predicate devices" and therefore "clinical studies were not required to support substantial equivalence" for its broader functionality. The following information pertains specifically to the UDFF feature.

Acceptance Criteria and Device Performance (UDFF Feature)

Further Study Details for UDFF Feature:

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Study 1: N = 30 subjects
     • Ethnicity/Country: 15 from USA, 15 from Korea
     • Sex: 15 Male, 15 Female
     • Retrospective or Prospective: Not explicitly stated, but the description of "To verify the clinical reliability...To record the UDFF measurement acquisition time" suggests it was a prospective data collection for this study.
   • Study 2: N = 28 subjects
     • Ethnicity/Country: 28 from Korea
     • Sex: 20 Male, 8 Female
     • Retrospective or Prospective: Not explicitly stated, but given the objective "To verify that UDFF of ACUSON Redwood shows good agreement with MRI-PDFF" and "To verify the clinical accuracy...", it implies prospective data collection where both UDFF and MRI-PDFF were acquired for correlation.

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

   • Study 1: This study primarily focused on comparing the ACUSON Redwood UDFF to the ACUSON Sequoia UDFF and internal consistency (test-retest reliability). Ground truth, in the sense of a definitive diagnostic outcome, was not the primary endpoint that would require expert adjudication. The "ground truth" here is the measurement from the established predicate device (ACUSON Sequoia UDFF) and the consistency of the Redwood's own measurements.
   • Study 2: The ground truth for this study was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). This MRI-PDFF is considered a quantitative reference standard for liver fat quantification. The document does not specify the number of human readers/experts directly involved in establishing the MRI-PDFF values for the study, as MRI-PDFF is typically an objective, quantitative measurement derived from MRI sequences and software, rather than a subjective expert read needing adjudication.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truths (predicate device measurements and MRI-PDFF) are presented as objective measurements and not subjective expert interpretations requiring adjudication.

4. 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or performed for the UDFF feature as described. The UDFF is a standalone software tool for measurement.

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

   • Yes, the studies evaluate the performance of the UDFF software tool itself in its ability to quantify fat fraction, either compared to a predicate device's software tool (Study 1) or to MRI-PDFF as a reference standard (Study 2). The results (Pearson Correlation, ICC, bland-Altman, AUROC) are metrics of the algorithm's performance.

6. The type of ground truth used:

   • Study 1: The ground truth was the Ultrasound-Derived Fat Fraction (UDFF) measurement obtained from the predicate device (ACUSON Sequoia), and the internal consistency of the ACUSON Redwood UDFF measurements (test-retest).
   • Study 2: The ground truth was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is a quantitative imaging biomarker considered a non-invasive gold standard for liver fat content.

7. The sample size for the training set:

   • The document does not provide information regarding the sample size of any training set used for the UDFF algorithm. This section focuses on validation studies.

8. How the ground truth for the training set was established:

   • The document does not provide information regarding how the ground truth for any potential training set was established.

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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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