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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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