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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This document is a 510(k) summary for the SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Apogee 3500, K102023).

The summary does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about reported device performance metrics.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Identification of the predicate device.
• Description of the device's operating modes and capabilities.
• Stated intended uses and clinical applications (abdominal, pediatric, small organs, musculo-skeletal, cardiac, and peripheral vascular, in B, M, PWD, Color Doppler, and 3D modes).
• Safety considerations and compliance with relevant medical device safety standards (NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5, ISO 10993-10).
• FDA's substantial equivalence determination letter.
• Detailed Indications for Use forms for the system and each associated transducer (C3L60C, L8L38C, C5L40C, P3F14C), specifying which clinical applications are "new indications" (denoted by "N") for various modes of operation.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

The closest information provided is the "Safety Considerations" section, which states: "The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008. The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10." This indicates that the device underwent testing for safety and compliance with general performance standards for ultrasound systems, but it does not detail any specific performance acceptance criteria or the results of such testing related to diagnostic accuracy or effectiveness.

In summary, the provided text does not contain the requested information regarding acceptance criteria, device performance metrics, or details of a study assessing such performance.

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