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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only), Specific (Tracks I & III) for the following clinical applications and modes of operation:
Ophthalmic (Ophthalmic), Fetal (B, M, PWD, CWD, Color Doppler, Combined, Other), Abdominal (B, M, PWD, Color Doppler, Combined, Other), Intra-operative (Spec.) (B, M, PWD, Color Doppler, Combined, Other), Intra-operative (Neuro.) (B, M, PWD, Color Doppler, Combined, Other), Laparoscopic (B, M, PWD, Color Doppler, Combined, Other), Pediatric (B, M, PWD, CWD, Color Doppler, Combined, Other), Small Organ (Spec.) (B, M, PWD, Color Doppler, Combined, Other), Neonatal Cephalic (B, M, PWD, Color Doppler, Combined, Other), Adult Cephalic (B, M, PWD, CWD, Color Doppler, Combined, Other), Trans-rectal (B, M, PWD, Color Doppler, Combined, Other), Trans-vaginal (B, M, PWD, Color Doppler, Combined, Other), Musculo-skel. (Convent.) (B, M, PWD, Color Doppler, Combined, Other), Musculo-skel. (Superfic.) (B, M, PWD, Color Doppler, Combined, Other), Cardiac Adult (B, M, PWD, CWD, Color Doppler, Combined, Other), Cardiac Pediatric (B, M, PWD, CWD, Color Doppler, Combined, Other), Trans-esophageal (card.) (B, M, PWD, Color Doppler, Combined, Other), Peripheral vessel (B, M, PWD, CWD, Color Doppler, Combined, Other).
Additional comments specify that certain indications include imaging for guidance of percutaneous biopsy, imaging of organs and structures exposed during surgery, and imaging of specific small organs.

The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions:

• B Mode
• M Mode
• Pulsed Doppler
• Continuous Wave Doppler
• Color Flow
• Amplitude Doppler
  It is also intended for Harmonic Imaging, Superficial Musculoskeletal Imaging, and 3D Imaging.

The provided document is a 510(k) premarket notification for the Hitachi EUB-5500 Diagnostic Ultrasound Scanner. It indicates the device's intended use and lists various transducers with their specific clinical applications and operating modes. However, it does not contain any information about acceptance criteria, study designs, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices by outlining compliance with safety standards and listing the intended uses for various transducers. It's a regulatory clearance document, not a clinical study report.

Therefore, I cannot provide the requested information from the given text. The text only describes the device and its regulatory clearance, not a study proving its performance against acceptance criteria.

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