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The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

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The provided text is a 510(k) premarket notification for the "NuWay Ultrasound Probe System." It primarily details the regulatory clearance for the device and its various transducers, listing the intended uses. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for studying the device's diagnostic performance.

The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance does not need to be independently proven against new acceptance criteria. Instead, it relies on the established safety and effectiveness of its predicate.

Therefore, I cannot provide the requested information from the given text.

Summary of what cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance by substantial equivalence, not performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No performance study details are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study details are included.
4. Adjudication method for the test set: Not present. No performance study details are included.
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 present. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No performance study details are included.
8. The sample size for the training set: Not present. This is a hardware device; no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not present. This is a hardware device; no training set for an algorithm is mentioned.

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