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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) including Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Other (spec.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Other (spec.), Peripheral vessel, Other (spec.).

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 Color Flow, Continuous Wave Doppler, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging, 4D imaging.

I am sorry, but the provided text only contains an FDA 510(k) premarket notification for the Hitachi EUB-5500 Diagnostic Ultrasound Scanner. It details the device description, safety compliance, and intended uses for various transducers.

The document does not describe any acceptance criteria for device performance, nor does it present any study or data proving the device meets acceptance criteria. It is primarily a regulatory filing for substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance, as it is not present in the given text.

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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.

Ask a specific question about this device